Elizabeth Mechcatie

Liraglutide has been approved as a weight loss agent for people who are obese and for people who are overweight and have at least one weight-related comorbidity, the Food and Drug Administration announced on Dec. 23.

The glucagon-like peptide-1 (GLP-1) receptor agonist is approved as an adjunct to a reduced calorie diet and increased physical activity in obese adults with a body mass index (BMI) of 30 kg/m² or greater and in overweight adults with a BMI of 27 kg/m² or greater and at least one weight-related condition such as hypertension, type 2 diabetes, or dyslipidemia.

Liraglutide, which is administered subcutaneously, was first approved in 2010 as a treatment for type 2 diabetes and is marketed for that indication as Victoza. Liraglutide will be marketed as Saxenda for the weight loss indication “and should not be used in combination with any other drug belonging to this class, including Victoza,” the FDA statement said. The liraglutide dose in Saxenda will be 3 mg; the dose in Victoza is 1.8 mg.

Approval for the weight loss indication was based on three studies of about 4,800 obese and overweight patients, who also received counseling about a reduced calorie diet and regular physical activity. In one study of patients who did not have diabetes, 62% of those on liraglutide and 34% of those on placebo lost at least 5% of their body weight over the course of a year. In another study of patients with type 2 diabetes, 49% of those on liraglutide and 16% of those on placebo lost at least 5% of their body weight in 1 year. Nausea, diarrhea, constipation, vomiting, and hypoglycemia were among the common adverse events associated with treatment, according to the FDA.

“Patients using Saxenda should be evaluated after 16 weeks to determine if the treatment is working,” the FDA statement said. “If a patient has not lost at least 4% of baseline body weight, Saxenda should be discontinued as it is unlikely that the patient will achieve and sustain clinically meaningful weight loss with continued treatment.”

Approval of Saxenda includes a Risk Evaluation and Mitigation Strategy (REMS), which outlines a plan to inform health care professionals about the risks associated with liraglutide. The drug’s label includes a boxed warning about cases of thyroid C-cell tumors associated with the drug in rat studies, with a recommendation that the drug not be used by patients with a personal or family history of medullary thyroid carcinoma (MTC) or by those with multiple endocrine neoplasia syndrome type 2. The manufacturer also is required to conduct several postmarketing studies, including a registry and at least 15 years of follow-up for MTC cases among patients treated with the drug.

Pancreatitis, gallbladder disease, and renal impairment are among the serious adverse events associated with the drug, which “can also raise heart rate and should be discontinued in patients who experience a sustained increase in resting heart rate,” the FDA statement said.

Liraglutide is manufactured by Novo Nordisk.

emechcatie@frontlinemedcom.com

Liraglutide has been approved as a weight loss agent for people who are obese and for people who are overweight and have at least one weight-related comorbidity, the Food and Drug Administration announced on Dec. 23.

The glucagon-like peptide-1 (GLP-1) receptor agonist is approved as an adjunct to a reduced calorie diet and increased physical activity in obese adults with a body mass index (BMI) of 30 kg/m² or greater and in overweight adults with a BMI of 27 kg/m² or greater and at least one weight-related condition such as hypertension, type 2 diabetes, or dyslipidemia.

Liraglutide, which is administered subcutaneously, was first approved in 2010 as a treatment for type 2 diabetes and is marketed for that indication as Victoza. Liraglutide will be marketed as Saxenda for the weight loss indication “and should not be used in combination with any other drug belonging to this class, including Victoza,” the FDA statement said. The liraglutide dose in Saxenda will be 3 mg; the dose in Victoza is 1.8 mg.

Approval for the weight loss indication was based on three studies of about 4,800 obese and overweight patients, who also received counseling about a reduced calorie diet and regular physical activity. In one study of patients who did not have diabetes, 62% of those on liraglutide and 34% of those on placebo lost at least 5% of their body weight over the course of a year. In another study of patients with type 2 diabetes, 49% of those on liraglutide and 16% of those on placebo lost at least 5% of their body weight in 1 year. Nausea, diarrhea, constipation, vomiting, and hypoglycemia were among the common adverse events associated with treatment, according to the FDA.

“Patients using Saxenda should be evaluated after 16 weeks to determine if the treatment is working,” the FDA statement said. “If a patient has not lost at least 4% of baseline body weight, Saxenda should be discontinued as it is unlikely that the patient will achieve and sustain clinically meaningful weight loss with continued treatment.”

Approval of Saxenda includes a Risk Evaluation and Mitigation Strategy (REMS), which outlines a plan to inform health care professionals about the risks associated with liraglutide. The drug’s label includes a boxed warning about cases of thyroid C-cell tumors associated with the drug in rat studies, with a recommendation that the drug not be used by patients with a personal or family history of medullary thyroid carcinoma (MTC) or by those with multiple endocrine neoplasia syndrome type 2. The manufacturer also is required to conduct several postmarketing studies, including a registry and at least 15 years of follow-up for MTC cases among patients treated with the drug.

Pancreatitis, gallbladder disease, and renal impairment are among the serious adverse events associated with the drug, which “can also raise heart rate and should be discontinued in patients who experience a sustained increase in resting heart rate,” the FDA statement said.

Liraglutide is manufactured by Novo Nordisk.

emechcatie@frontlinemedcom.com

Liraglutide has been approved as a weight loss agent for people who are obese and for people who are overweight and have at least one weight-related comorbidity, the Food and Drug Administration announced on Dec. 23.

The glucagon-like peptide-1 (GLP-1) receptor agonist is approved as an adjunct to a reduced calorie diet and increased physical activity in obese adults with a body mass index (BMI) of 30 kg/m² or greater and in overweight adults with a BMI of 27 kg/m² or greater and at least one weight-related condition such as hypertension, type 2 diabetes, or dyslipidemia.

Liraglutide, which is administered subcutaneously, was first approved in 2010 as a treatment for type 2 diabetes and is marketed for that indication as Victoza. Liraglutide will be marketed as Saxenda for the weight loss indication “and should not be used in combination with any other drug belonging to this class, including Victoza,” the FDA statement said. The liraglutide dose in Saxenda will be 3 mg; the dose in Victoza is 1.8 mg.

Approval for the weight loss indication was based on three studies of about 4,800 obese and overweight patients, who also received counseling about a reduced calorie diet and regular physical activity. In one study of patients who did not have diabetes, 62% of those on liraglutide and 34% of those on placebo lost at least 5% of their body weight over the course of a year. In another study of patients with type 2 diabetes, 49% of those on liraglutide and 16% of those on placebo lost at least 5% of their body weight in 1 year. Nausea, diarrhea, constipation, vomiting, and hypoglycemia were among the common adverse events associated with treatment, according to the FDA.

“Patients using Saxenda should be evaluated after 16 weeks to determine if the treatment is working,” the FDA statement said. “If a patient has not lost at least 4% of baseline body weight, Saxenda should be discontinued as it is unlikely that the patient will achieve and sustain clinically meaningful weight loss with continued treatment.”

Approval of Saxenda includes a Risk Evaluation and Mitigation Strategy (REMS), which outlines a plan to inform health care professionals about the risks associated with liraglutide. The drug’s label includes a boxed warning about cases of thyroid C-cell tumors associated with the drug in rat studies, with a recommendation that the drug not be used by patients with a personal or family history of medullary thyroid carcinoma (MTC) or by those with multiple endocrine neoplasia syndrome type 2. The manufacturer also is required to conduct several postmarketing studies, including a registry and at least 15 years of follow-up for MTC cases among patients treated with the drug.

Pancreatitis, gallbladder disease, and renal impairment are among the serious adverse events associated with the drug, which “can also raise heart rate and should be discontinued in patients who experience a sustained increase in resting heart rate,” the FDA statement said.

Liraglutide is manufactured by Novo Nordisk.

emechcatie@frontlinemedcom.com

In 2015, the Food and Drug Administration will issue a draft guidance recommending that men who have sex with men can donate blood 1 year after their last sexual contact with another man, replacing the longstanding policy that this group be deferred from donating blood indefinitely, the agency announced on Dec. 23.

The recommendation, under consideration for several years, is based on available scientific evidence, including epidemiologic data and statistical modeling of the impact of this policy change would have on blood supply safety; as well as recommendations of FDA and Department of Health and Human Services advisory committees, Dr. Peter Marks, deputy director of the FDA Center for Biologics Evaluation and Research, said during a press conference.

©Tomasz Gierygowski/thinkstockphotos.com

“Some of the most compelling data in favor of policy change come from Australia,” where HIV epidemiology is similar to that in the United States, Dr. Marks said.

Studies using a national blood surveillance system during the decade after the policy was changed in Australia from indefinite deferral of men who have sex with men (MSM) to 1 year deferral, as proposed in the United States, “documented no adverse effects” on the safety of the country’s blood supply, Dr. Marks said.

The FDA has also been working with the National Heart, Lung, and Blood Institute to implement a surveillance system to monitor the effect of the policy change on the safety of the blood supply. As the data are collected, the policy will be revisited, Dr. Marks said. The proposed policy change will also better align with the blood donor deferral period recommended for other men and women at increased risk of HIV infection, he noted.

Dr. Marks said that the currently available scientific data do not support shortening the deferral period to less than 1 year.

At a meeting in November, the federal Advisory Committee on Blood and Tissue Safety and Availability voted 16-2 to support the 1 year deferral policy for MSM.

The draft guidance will be published in the Federal Register in 2015 and will allow the public to submit comments. Dr. Marks said he could not predict whether the actual policy change would go into effect in 2015.

emechcatie@frontlinemedcom.com

In 2015, the Food and Drug Administration will issue a draft guidance recommending that men who have sex with men can donate blood 1 year after their last sexual contact with another man, replacing the longstanding policy that this group be deferred from donating blood indefinitely, the agency announced on Dec. 23.

The recommendation, under consideration for several years, is based on available scientific evidence, including epidemiologic data and statistical modeling of the impact of this policy change would have on blood supply safety; as well as recommendations of FDA and Department of Health and Human Services advisory committees, Dr. Peter Marks, deputy director of the FDA Center for Biologics Evaluation and Research, said during a press conference.

©Tomasz Gierygowski/thinkstockphotos.com

“Some of the most compelling data in favor of policy change come from Australia,” where HIV epidemiology is similar to that in the United States, Dr. Marks said.

Studies using a national blood surveillance system during the decade after the policy was changed in Australia from indefinite deferral of men who have sex with men (MSM) to 1 year deferral, as proposed in the United States, “documented no adverse effects” on the safety of the country’s blood supply, Dr. Marks said.

The FDA has also been working with the National Heart, Lung, and Blood Institute to implement a surveillance system to monitor the effect of the policy change on the safety of the blood supply. As the data are collected, the policy will be revisited, Dr. Marks said. The proposed policy change will also better align with the blood donor deferral period recommended for other men and women at increased risk of HIV infection, he noted.

Dr. Marks said that the currently available scientific data do not support shortening the deferral period to less than 1 year.

At a meeting in November, the federal Advisory Committee on Blood and Tissue Safety and Availability voted 16-2 to support the 1 year deferral policy for MSM.

The draft guidance will be published in the Federal Register in 2015 and will allow the public to submit comments. Dr. Marks said he could not predict whether the actual policy change would go into effect in 2015.

emechcatie@frontlinemedcom.com

In 2015, the Food and Drug Administration will issue a draft guidance recommending that men who have sex with men can donate blood 1 year after their last sexual contact with another man, replacing the longstanding policy that this group be deferred from donating blood indefinitely, the agency announced on Dec. 23.

The recommendation, under consideration for several years, is based on available scientific evidence, including epidemiologic data and statistical modeling of the impact of this policy change would have on blood supply safety; as well as recommendations of FDA and Department of Health and Human Services advisory committees, Dr. Peter Marks, deputy director of the FDA Center for Biologics Evaluation and Research, said during a press conference.

©Tomasz Gierygowski/thinkstockphotos.com

“Some of the most compelling data in favor of policy change come from Australia,” where HIV epidemiology is similar to that in the United States, Dr. Marks said.

Studies using a national blood surveillance system during the decade after the policy was changed in Australia from indefinite deferral of men who have sex with men (MSM) to 1 year deferral, as proposed in the United States, “documented no adverse effects” on the safety of the country’s blood supply, Dr. Marks said.

The FDA has also been working with the National Heart, Lung, and Blood Institute to implement a surveillance system to monitor the effect of the policy change on the safety of the blood supply. As the data are collected, the policy will be revisited, Dr. Marks said. The proposed policy change will also better align with the blood donor deferral period recommended for other men and women at increased risk of HIV infection, he noted.

Dr. Marks said that the currently available scientific data do not support shortening the deferral period to less than 1 year.

At a meeting in November, the federal Advisory Committee on Blood and Tissue Safety and Availability voted 16-2 to support the 1 year deferral policy for MSM.

The draft guidance will be published in the Federal Register in 2015 and will allow the public to submit comments. Dr. Marks said he could not predict whether the actual policy change would go into effect in 2015.

emechcatie@frontlinemedcom.com

Peramivir, an intravenously administered neuraminidase inhibitor, has been approved for treating acute uncomplicated influenza in adults aged 18 years and older, who “have shown symptoms of flu for no more than two days,” the Food and Drug Administration announced on Dec. 22.*

It is administered as a single IV dose, and will be marketed as Rapivab, by BioCryst Pharmaceuticals.

“Rapivab is the third neuraminidase inhibitor approved by the FDA to treat flu infection, but the first approved as an IV formulation,” Dr. Edward Cox, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, said in the statement. The drug inhibits the viral neuraminidase, which releases virus particles from infected cells.

“The availability of a single-dose, intravenous option for the treatment of acute uncomplicated flu allows health care professionals and patients to have a choice based on an individual patient’s needs,” he added.

Approval was based on a study of 297 people with confirmed influenza, randomized to 300 mg or 600 mg of peramivir, or placebo.

“Overall, participants receiving Rapivab 600 mg had their combined influenza symptoms alleviated 21 hours sooner, on average, than those receiving placebo, which is consistent with other drugs in the same class,” and those on the 600 mg dose “also recovered to normal temperature approximately 12 hours sooner compared to placebo,” the statement said. These findings were confirmed in supportive studies, but “efficacy could not be established in patients with serious influenza requiring hospitalization,” the statement added.

Diarrhea was among the common adverse events associated with peramivir; rare, serious adverse events included serious skin or hypersensitivity reactions such as Stevens-Johnson syndrome and erythema multiforme, according to the FDA.

The two previously approved neuraminidase inhibitors are oseltamivir (Tamiflu), which is administered orally, and zanamivir (Relenza), which is inhaled.

*Correction, 12/23/2014: An earlier version of this story misstated the date Peramivir was approved.

emechcatie@frontlinemedcom.com

Peramivir, an intravenously administered neuraminidase inhibitor, has been approved for treating acute uncomplicated influenza in adults aged 18 years and older, who “have shown symptoms of flu for no more than two days,” the Food and Drug Administration announced on Dec. 22.*

It is administered as a single IV dose, and will be marketed as Rapivab, by BioCryst Pharmaceuticals.

“Rapivab is the third neuraminidase inhibitor approved by the FDA to treat flu infection, but the first approved as an IV formulation,” Dr. Edward Cox, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, said in the statement. The drug inhibits the viral neuraminidase, which releases virus particles from infected cells.

“The availability of a single-dose, intravenous option for the treatment of acute uncomplicated flu allows health care professionals and patients to have a choice based on an individual patient’s needs,” he added.

Approval was based on a study of 297 people with confirmed influenza, randomized to 300 mg or 600 mg of peramivir, or placebo.

“Overall, participants receiving Rapivab 600 mg had their combined influenza symptoms alleviated 21 hours sooner, on average, than those receiving placebo, which is consistent with other drugs in the same class,” and those on the 600 mg dose “also recovered to normal temperature approximately 12 hours sooner compared to placebo,” the statement said. These findings were confirmed in supportive studies, but “efficacy could not be established in patients with serious influenza requiring hospitalization,” the statement added.

Diarrhea was among the common adverse events associated with peramivir; rare, serious adverse events included serious skin or hypersensitivity reactions such as Stevens-Johnson syndrome and erythema multiforme, according to the FDA.

The two previously approved neuraminidase inhibitors are oseltamivir (Tamiflu), which is administered orally, and zanamivir (Relenza), which is inhaled.

*Correction, 12/23/2014: An earlier version of this story misstated the date Peramivir was approved.

emechcatie@frontlinemedcom.com

Peramivir, an intravenously administered neuraminidase inhibitor, has been approved for treating acute uncomplicated influenza in adults aged 18 years and older, who “have shown symptoms of flu for no more than two days,” the Food and Drug Administration announced on Dec. 22.*

It is administered as a single IV dose, and will be marketed as Rapivab, by BioCryst Pharmaceuticals.

“Rapivab is the third neuraminidase inhibitor approved by the FDA to treat flu infection, but the first approved as an IV formulation,” Dr. Edward Cox, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, said in the statement. The drug inhibits the viral neuraminidase, which releases virus particles from infected cells.

“The availability of a single-dose, intravenous option for the treatment of acute uncomplicated flu allows health care professionals and patients to have a choice based on an individual patient’s needs,” he added.

Approval was based on a study of 297 people with confirmed influenza, randomized to 300 mg or 600 mg of peramivir, or placebo.

“Overall, participants receiving Rapivab 600 mg had their combined influenza symptoms alleviated 21 hours sooner, on average, than those receiving placebo, which is consistent with other drugs in the same class,” and those on the 600 mg dose “also recovered to normal temperature approximately 12 hours sooner compared to placebo,” the statement said. These findings were confirmed in supportive studies, but “efficacy could not be established in patients with serious influenza requiring hospitalization,” the statement added.

Diarrhea was among the common adverse events associated with peramivir; rare, serious adverse events included serious skin or hypersensitivity reactions such as Stevens-Johnson syndrome and erythema multiforme, according to the FDA.

The two previously approved neuraminidase inhibitors are oseltamivir (Tamiflu), which is administered orally, and zanamivir (Relenza), which is inhaled.

*Correction, 12/23/2014: An earlier version of this story misstated the date Peramivir was approved.

emechcatie@frontlinemedcom.com

Olaparib, a poly ADP-ribose polymerase (PARP) inhibitor, has been approved for treating advanced ovarian cancer associated with defective BRCA genes, the Food and Drug Administration announced on Dec. 19.

Olaparib “is the first of a new class of drugs for treating ovarian cancer,” Dr. Richard Pazdur, director of the office of hematology and oncology Products in the FDA’s Center for Drug Evaluation and Research, said in the statement announcing approval. Olaparib “is approved for patients with specific abnormalities in the BRCA gene and is an example of how a greater understanding of the underlying mechanisms of disease can lead to targeted, more personalized treatment,” he added.

Olaparib will be marketed as Lynparza, by Astra Zeneca Pharmaceuticals. It was approved with a companion diagnostic test for BRCA gene mutations, the BRCA test – the BRACAnalysis CDx – is manufactured by Myriad Genetic Laboratories, which will also perform the tests.

The recommended dose is 400 mg taken twice a day, continued until the disease progresses or toxicity becomes unacceptable.

The specific approved indication is as monotherapy “in patients with deleterious or suspected deleterious germline BRCA mutated (as detected by an FDA-approved test) advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy,” according to the prescribing information. The prescribing information also includes the statement that this is an accelerated approval, which is based on the objective response rate and duration of response, and “continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.”

The use of olaparib as maintenance therapy for ovarian cancer was reviewed at a meeting of an FDA advisory panel meeting in June, where most of the panel voted that the data did not support accelerated approval for this indication. After that meeting, AstraZeneca submitted data supportive of the indication that has been approved, according to the FDA statement.

In a study of 137 women with gBRCAm-associated ovarian cancer who were treated with olaparib, 34% had an objective response rate for an average of 7.9 months, according to the FDA.

Common adverse events associated with treatment included nausea, fatigue, vomiting, diarrhea, dysgeusia, headache, myalgia, and dermatitis, according to the FDA. Serious adverse events included myelodysplastic syndrome, acute myeloid leukemia, and pneumonitis.

emechcatie@frontlinemedcom.com

Olaparib, a poly ADP-ribose polymerase (PARP) inhibitor, has been approved for treating advanced ovarian cancer associated with defective BRCA genes, the Food and Drug Administration announced on Dec. 19.

Olaparib “is the first of a new class of drugs for treating ovarian cancer,” Dr. Richard Pazdur, director of the office of hematology and oncology Products in the FDA’s Center for Drug Evaluation and Research, said in the statement announcing approval. Olaparib “is approved for patients with specific abnormalities in the BRCA gene and is an example of how a greater understanding of the underlying mechanisms of disease can lead to targeted, more personalized treatment,” he added.

Olaparib will be marketed as Lynparza, by Astra Zeneca Pharmaceuticals. It was approved with a companion diagnostic test for BRCA gene mutations, the BRCA test – the BRACAnalysis CDx – is manufactured by Myriad Genetic Laboratories, which will also perform the tests.

The recommended dose is 400 mg taken twice a day, continued until the disease progresses or toxicity becomes unacceptable.

The specific approved indication is as monotherapy “in patients with deleterious or suspected deleterious germline BRCA mutated (as detected by an FDA-approved test) advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy,” according to the prescribing information. The prescribing information also includes the statement that this is an accelerated approval, which is based on the objective response rate and duration of response, and “continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.”

The use of olaparib as maintenance therapy for ovarian cancer was reviewed at a meeting of an FDA advisory panel meeting in June, where most of the panel voted that the data did not support accelerated approval for this indication. After that meeting, AstraZeneca submitted data supportive of the indication that has been approved, according to the FDA statement.

In a study of 137 women with gBRCAm-associated ovarian cancer who were treated with olaparib, 34% had an objective response rate for an average of 7.9 months, according to the FDA.

Common adverse events associated with treatment included nausea, fatigue, vomiting, diarrhea, dysgeusia, headache, myalgia, and dermatitis, according to the FDA. Serious adverse events included myelodysplastic syndrome, acute myeloid leukemia, and pneumonitis.

emechcatie@frontlinemedcom.com

Olaparib, a poly ADP-ribose polymerase (PARP) inhibitor, has been approved for treating advanced ovarian cancer associated with defective BRCA genes, the Food and Drug Administration announced on Dec. 19.

Olaparib “is the first of a new class of drugs for treating ovarian cancer,” Dr. Richard Pazdur, director of the office of hematology and oncology Products in the FDA’s Center for Drug Evaluation and Research, said in the statement announcing approval. Olaparib “is approved for patients with specific abnormalities in the BRCA gene and is an example of how a greater understanding of the underlying mechanisms of disease can lead to targeted, more personalized treatment,” he added.

Olaparib will be marketed as Lynparza, by Astra Zeneca Pharmaceuticals. It was approved with a companion diagnostic test for BRCA gene mutations, the BRCA test – the BRACAnalysis CDx – is manufactured by Myriad Genetic Laboratories, which will also perform the tests.

The recommended dose is 400 mg taken twice a day, continued until the disease progresses or toxicity becomes unacceptable.

The specific approved indication is as monotherapy “in patients with deleterious or suspected deleterious germline BRCA mutated (as detected by an FDA-approved test) advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy,” according to the prescribing information. The prescribing information also includes the statement that this is an accelerated approval, which is based on the objective response rate and duration of response, and “continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.”

The use of olaparib as maintenance therapy for ovarian cancer was reviewed at a meeting of an FDA advisory panel meeting in June, where most of the panel voted that the data did not support accelerated approval for this indication. After that meeting, AstraZeneca submitted data supportive of the indication that has been approved, according to the FDA statement.

In a study of 137 women with gBRCAm-associated ovarian cancer who were treated with olaparib, 34% had an objective response rate for an average of 7.9 months, according to the FDA.

Common adverse events associated with treatment included nausea, fatigue, vomiting, diarrhea, dysgeusia, headache, myalgia, and dermatitis, according to the FDA. Serious adverse events included myelodysplastic syndrome, acute myeloid leukemia, and pneumonitis.

emechcatie@frontlinemedcom.com

AVENTURA, FLA. – Treatment with naltrexone* was associated with reductions in drinking over 3 months in a study of alcohol-dependent adults, but whether these individuals had a polymorphism that has been associated with better responses to the drug in previous studies did not affect outcomes, Dr. David W. Oslin reported at the annual meeting of the American Academy of Addiction Psychiatry.

“We did not find that naltrexone ... was moderated by genotype in this prospective trial,” said Dr. Oslin, professor of medicine at the University of Pennsylvania, Philadelphia.

Naltrexone, an opioid antagonist approved by the Food and Drug Administration for treating alcohol dependence, acts principally on the mu opioid receptor.

Elizabeth Mechcatie/Frontline Medical News

Various types of studies have shown that the Asp40 allele of OPRM1, the gene that encodes for the mu-opioid receptor, is functionally active and might predict response to treatment with naltrexone , Dr. Oslin said. Studies have found that individuals with the Asp40 allele had better responses to naltrexone . A preliminary study led by Dr. Oslin found that those who had one or two copies of the Asp40 allele had significantly lower relapse rates and a longer time to return to heavy drinking than did those who had only the Asn40 allele (Neuropsychopharmacology 2003;28:1546-52). A meta-analysis of observational clinical studies of patients treated with naltrexone found that those patients with the Asp40 allele were twice as likely not to relapse than were those who were homozygous for the Asn40 allele.

In another study, the COMBINE trial, which found a “robust” effect of treatment with naltrexone over placebo among those with the Asp40 allele, “naltrexone seemed to be moderated by the presence of the Asp40 allele,” with “essentially no effect” of naltrexone in the homozygous (Asn40/Asn40) group, he noted Arch Gen Psychiatry 2008;65:135-44). In all these studies, Dr. Oslin pointed out that genotyping was performed retrospectively.

But in the study he presented, genotyping was performed as part of the study, a prospective, double-blind, placebo-controlled study of 221 alcohol-dependent adults, mostly men (mean age 46-51 years). Most had undergone addiction treatment previously. Patients with one or two copies of the Asp40 allele and those who were homozygous for the Asn40 allele were randomized to naltrexone 50 mg a day or placebo and the primary outcome measured was relapse to heavy drinking during treatment.

In the group overall, there was a “moderate to small” effect of naltrexone on the primary outcome over 12 weeks of treatment, but no statistically significant differences on responses by genotype, Dr. Oslin said. There was also no effect of genotype on craving, abstinence, or percent days of drinking, or any drinking.

Some differences in adverse events were found by genotype: Among those with the Asn40 allele, fatigue, nausea, sensory problems, and upper respiratory infections were more for those who received naltrexone than for those who received placebo. Among those with the Asp40 allele, nausea and upper GI problems were more common for those on naltrexone than for those on placebo. Adverse events were slightly more common in the N/ASP40 group, he said.

Overall, the results of the study supported a moderate effect of naltrexone, similar to that seen in previous studies, but the lack of a genotype effect is not an indication it does not exist, Dr. Oslin said.

As to why the results were not what they expected, he speculated that age could be an explanation and that “the Asp40 dopamine release cascade may be more relevant “on cravings in younger people with alcohol dependence. The individuals in this study were in their 40s and 50s on average, most had been alcoholics for years, and they had more severe addictions to drinking than in some of the other studies, so “the dopamine response to craving may not be as relevant.”

While the study does not indicate that this single nucleotide polymorphism is not “robustly functional,” based on the current literature, it “doesn’t add to our clinical management” at this time, Dr. Oslin said. “We are in our infancy really in understanding how genetics influences treatment.”

The study received funding from the National Institutes of Health and the Department of Veterans Affairs. Dr. Oslin and five coinvestigators reported no conflicts; another investigator received funding from Alkermes at the time of the grant as a consultant on depot naltrexone.

emechcatie@frontlinemedcom.com

*Correction, 12/19/2014: An earlier version of this article incorrectly identified the drug naltrexone. 

AVENTURA, FLA. – Treatment with naltrexone* was associated with reductions in drinking over 3 months in a study of alcohol-dependent adults, but whether these individuals had a polymorphism that has been associated with better responses to the drug in previous studies did not affect outcomes, Dr. David W. Oslin reported at the annual meeting of the American Academy of Addiction Psychiatry.

“We did not find that naltrexone ... was moderated by genotype in this prospective trial,” said Dr. Oslin, professor of medicine at the University of Pennsylvania, Philadelphia.

Naltrexone, an opioid antagonist approved by the Food and Drug Administration for treating alcohol dependence, acts principally on the mu opioid receptor.

Elizabeth Mechcatie/Frontline Medical News

Various types of studies have shown that the Asp40 allele of OPRM1, the gene that encodes for the mu-opioid receptor, is functionally active and might predict response to treatment with naltrexone , Dr. Oslin said. Studies have found that individuals with the Asp40 allele had better responses to naltrexone . A preliminary study led by Dr. Oslin found that those who had one or two copies of the Asp40 allele had significantly lower relapse rates and a longer time to return to heavy drinking than did those who had only the Asn40 allele (Neuropsychopharmacology 2003;28:1546-52). A meta-analysis of observational clinical studies of patients treated with naltrexone found that those patients with the Asp40 allele were twice as likely not to relapse than were those who were homozygous for the Asn40 allele.

In another study, the COMBINE trial, which found a “robust” effect of treatment with naltrexone over placebo among those with the Asp40 allele, “naltrexone seemed to be moderated by the presence of the Asp40 allele,” with “essentially no effect” of naltrexone in the homozygous (Asn40/Asn40) group, he noted Arch Gen Psychiatry 2008;65:135-44). In all these studies, Dr. Oslin pointed out that genotyping was performed retrospectively.

But in the study he presented, genotyping was performed as part of the study, a prospective, double-blind, placebo-controlled study of 221 alcohol-dependent adults, mostly men (mean age 46-51 years). Most had undergone addiction treatment previously. Patients with one or two copies of the Asp40 allele and those who were homozygous for the Asn40 allele were randomized to naltrexone 50 mg a day or placebo and the primary outcome measured was relapse to heavy drinking during treatment.

In the group overall, there was a “moderate to small” effect of naltrexone on the primary outcome over 12 weeks of treatment, but no statistically significant differences on responses by genotype, Dr. Oslin said. There was also no effect of genotype on craving, abstinence, or percent days of drinking, or any drinking.

Some differences in adverse events were found by genotype: Among those with the Asn40 allele, fatigue, nausea, sensory problems, and upper respiratory infections were more for those who received naltrexone than for those who received placebo. Among those with the Asp40 allele, nausea and upper GI problems were more common for those on naltrexone than for those on placebo. Adverse events were slightly more common in the N/ASP40 group, he said.

Overall, the results of the study supported a moderate effect of naltrexone, similar to that seen in previous studies, but the lack of a genotype effect is not an indication it does not exist, Dr. Oslin said.

As to why the results were not what they expected, he speculated that age could be an explanation and that “the Asp40 dopamine release cascade may be more relevant “on cravings in younger people with alcohol dependence. The individuals in this study were in their 40s and 50s on average, most had been alcoholics for years, and they had more severe addictions to drinking than in some of the other studies, so “the dopamine response to craving may not be as relevant.”

While the study does not indicate that this single nucleotide polymorphism is not “robustly functional,” based on the current literature, it “doesn’t add to our clinical management” at this time, Dr. Oslin said. “We are in our infancy really in understanding how genetics influences treatment.”

The study received funding from the National Institutes of Health and the Department of Veterans Affairs. Dr. Oslin and five coinvestigators reported no conflicts; another investigator received funding from Alkermes at the time of the grant as a consultant on depot naltrexone.

emechcatie@frontlinemedcom.com

*Correction, 12/19/2014: An earlier version of this article incorrectly identified the drug naltrexone. 

AVENTURA, FLA. – Treatment with naltrexone* was associated with reductions in drinking over 3 months in a study of alcohol-dependent adults, but whether these individuals had a polymorphism that has been associated with better responses to the drug in previous studies did not affect outcomes, Dr. David W. Oslin reported at the annual meeting of the American Academy of Addiction Psychiatry.

“We did not find that naltrexone ... was moderated by genotype in this prospective trial,” said Dr. Oslin, professor of medicine at the University of Pennsylvania, Philadelphia.

Naltrexone, an opioid antagonist approved by the Food and Drug Administration for treating alcohol dependence, acts principally on the mu opioid receptor.

Elizabeth Mechcatie/Frontline Medical News

Various types of studies have shown that the Asp40 allele of OPRM1, the gene that encodes for the mu-opioid receptor, is functionally active and might predict response to treatment with naltrexone , Dr. Oslin said. Studies have found that individuals with the Asp40 allele had better responses to naltrexone . A preliminary study led by Dr. Oslin found that those who had one or two copies of the Asp40 allele had significantly lower relapse rates and a longer time to return to heavy drinking than did those who had only the Asn40 allele (Neuropsychopharmacology 2003;28:1546-52). A meta-analysis of observational clinical studies of patients treated with naltrexone found that those patients with the Asp40 allele were twice as likely not to relapse than were those who were homozygous for the Asn40 allele.

In another study, the COMBINE trial, which found a “robust” effect of treatment with naltrexone over placebo among those with the Asp40 allele, “naltrexone seemed to be moderated by the presence of the Asp40 allele,” with “essentially no effect” of naltrexone in the homozygous (Asn40/Asn40) group, he noted Arch Gen Psychiatry 2008;65:135-44). In all these studies, Dr. Oslin pointed out that genotyping was performed retrospectively.

But in the study he presented, genotyping was performed as part of the study, a prospective, double-blind, placebo-controlled study of 221 alcohol-dependent adults, mostly men (mean age 46-51 years). Most had undergone addiction treatment previously. Patients with one or two copies of the Asp40 allele and those who were homozygous for the Asn40 allele were randomized to naltrexone 50 mg a day or placebo and the primary outcome measured was relapse to heavy drinking during treatment.

In the group overall, there was a “moderate to small” effect of naltrexone on the primary outcome over 12 weeks of treatment, but no statistically significant differences on responses by genotype, Dr. Oslin said. There was also no effect of genotype on craving, abstinence, or percent days of drinking, or any drinking.

Some differences in adverse events were found by genotype: Among those with the Asn40 allele, fatigue, nausea, sensory problems, and upper respiratory infections were more for those who received naltrexone than for those who received placebo. Among those with the Asp40 allele, nausea and upper GI problems were more common for those on naltrexone than for those on placebo. Adverse events were slightly more common in the N/ASP40 group, he said.

Overall, the results of the study supported a moderate effect of naltrexone, similar to that seen in previous studies, but the lack of a genotype effect is not an indication it does not exist, Dr. Oslin said.

As to why the results were not what they expected, he speculated that age could be an explanation and that “the Asp40 dopamine release cascade may be more relevant “on cravings in younger people with alcohol dependence. The individuals in this study were in their 40s and 50s on average, most had been alcoholics for years, and they had more severe addictions to drinking than in some of the other studies, so “the dopamine response to craving may not be as relevant.”

While the study does not indicate that this single nucleotide polymorphism is not “robustly functional,” based on the current literature, it “doesn’t add to our clinical management” at this time, Dr. Oslin said. “We are in our infancy really in understanding how genetics influences treatment.”

The study received funding from the National Institutes of Health and the Department of Veterans Affairs. Dr. Oslin and five coinvestigators reported no conflicts; another investigator received funding from Alkermes at the time of the grant as a consultant on depot naltrexone.

emechcatie@frontlinemedcom.com

*Correction, 12/19/2014: An earlier version of this article incorrectly identified the drug naltrexone. 

A long-acting formulation of the somatostatin analogue pasireotide has been approved for treatment of acromegaly in patients “who have had an inadequate response to surgery and/or for whom surgery is not an option,” the manufacturer, Novartis, has announced.

In a Dec. 16 statement, the company said that Food and Drug Administration approval was based on two phase III studies, one that enrolled medically naive patients with the rare endocrine disorder who had surgery previously or for whom surgery was not an option, and a study of patients who were not adequately controlled on treatment with other somatostatin analogues (SSAs). Treatment was effective in both populations, based on “higher rates of full biochemical control” (mean GH level under 2.5 mcg/L and normal IGF-1 levels) among those treated with long-acting pasireotide compared with the other SSA, according to Novartis.

The most common adverse events associated with treatment, affecting at least 20% of patients, were cholelithiasis, hyperglycemia, and diabetes, according to the prescribing information, which includes a warning about the risk of hyperglycemia and diabetes, bradycardia and QT prolongation, liver test elevations, and cholelithiasis.

A regular formulation of pasireotide was approved by the FDA in 2012, for the treatment of adults with Cushing’s disease “for whom pituitary surgery is not an option or has not been curative.” It is marketed as Signifor. The long-acting formulation, administered intramuscularly once a month, will be marketed as Signifor LAR . In November 2014, it was approved in Europe for the acromegaly indication, Novartis said.

emechcatie@frontlinemedcom.com

A long-acting formulation of the somatostatin analogue pasireotide has been approved for treatment of acromegaly in patients “who have had an inadequate response to surgery and/or for whom surgery is not an option,” the manufacturer, Novartis, has announced.

In a Dec. 16 statement, the company said that Food and Drug Administration approval was based on two phase III studies, one that enrolled medically naive patients with the rare endocrine disorder who had surgery previously or for whom surgery was not an option, and a study of patients who were not adequately controlled on treatment with other somatostatin analogues (SSAs). Treatment was effective in both populations, based on “higher rates of full biochemical control” (mean GH level under 2.5 mcg/L and normal IGF-1 levels) among those treated with long-acting pasireotide compared with the other SSA, according to Novartis.

The most common adverse events associated with treatment, affecting at least 20% of patients, were cholelithiasis, hyperglycemia, and diabetes, according to the prescribing information, which includes a warning about the risk of hyperglycemia and diabetes, bradycardia and QT prolongation, liver test elevations, and cholelithiasis.

A regular formulation of pasireotide was approved by the FDA in 2012, for the treatment of adults with Cushing’s disease “for whom pituitary surgery is not an option or has not been curative.” It is marketed as Signifor. The long-acting formulation, administered intramuscularly once a month, will be marketed as Signifor LAR . In November 2014, it was approved in Europe for the acromegaly indication, Novartis said.

emechcatie@frontlinemedcom.com

A long-acting formulation of the somatostatin analogue pasireotide has been approved for treatment of acromegaly in patients “who have had an inadequate response to surgery and/or for whom surgery is not an option,” the manufacturer, Novartis, has announced.

In a Dec. 16 statement, the company said that Food and Drug Administration approval was based on two phase III studies, one that enrolled medically naive patients with the rare endocrine disorder who had surgery previously or for whom surgery was not an option, and a study of patients who were not adequately controlled on treatment with other somatostatin analogues (SSAs). Treatment was effective in both populations, based on “higher rates of full biochemical control” (mean GH level under 2.5 mcg/L and normal IGF-1 levels) among those treated with long-acting pasireotide compared with the other SSA, according to Novartis.

The most common adverse events associated with treatment, affecting at least 20% of patients, were cholelithiasis, hyperglycemia, and diabetes, according to the prescribing information, which includes a warning about the risk of hyperglycemia and diabetes, bradycardia and QT prolongation, liver test elevations, and cholelithiasis.

A regular formulation of pasireotide was approved by the FDA in 2012, for the treatment of adults with Cushing’s disease “for whom pituitary surgery is not an option or has not been curative.” It is marketed as Signifor. The long-acting formulation, administered intramuscularly once a month, will be marketed as Signifor LAR . In November 2014, it was approved in Europe for the acromegaly indication, Novartis said.

emechcatie@frontlinemedcom.com

A blood test that measures a biomarker for vascular inflammation has been cleared for use as a screening test for evaluating the risk of coronary heart disease events in adults with no history of heart disease, the Food and Drug Administration announced on Dec. 15.

Studies of the PLAC Test for Lp-PLA2 Activity, which measures the activity of lipoprotein-associated phospholipase A2 (Lp-PLA2), indicate that it is more accurate in determining risk in women, particularly black women, according to the FDA’s statement. “A cardiac test that helps better predict future CHD risk in women, and especially black women, may help health care professionals identify these patients before they experience a serious CHD event, like a heart attack,” Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health, said in the statement. “We hope the clearance of this test will improve preventative care and reduce CHD-related mortality and morbidity in these patients,” he added.

A test result over 225 nmol/min/mL indicates an increased risk for a cardiac event.

The FDA reviewed data from the Lp-PLA2 Activity study, a substudy from the National Institute of Health–sponsored Reasons for Geographic and Racial Differences in Stroke (REGARDS) project, which used the test in about 4,600 adults aged 45-92 years; 42% were men, 58% were women, 41.5% were black, and 58.5% were white. Over a median follow-up of 5.3 years, the rate of CHD events was 7% among those with a result that was over 225 nmol/min/mL and was about 3% among those with lower levels. Further analysis of subgroups “showed that black women experienced a higher jump in the rate of CHD events, compared with other participants when Lp-PLA2 levels were higher than 225 nmol/min/mL,” the statement said.

The manufacturer of the test is diaDexus, which defines Lp-PLA2 as a “vascular-specific inflammatory enzyme implicated in the formation of rupture-prone plaque.”

A blood test that measures a biomarker for vascular inflammation has been cleared for use as a screening test for evaluating the risk of coronary heart disease events in adults with no history of heart disease, the Food and Drug Administration announced on Dec. 15.

Studies of the PLAC Test for Lp-PLA2 Activity, which measures the activity of lipoprotein-associated phospholipase A2 (Lp-PLA2), indicate that it is more accurate in determining risk in women, particularly black women, according to the FDA’s statement. “A cardiac test that helps better predict future CHD risk in women, and especially black women, may help health care professionals identify these patients before they experience a serious CHD event, like a heart attack,” Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health, said in the statement. “We hope the clearance of this test will improve preventative care and reduce CHD-related mortality and morbidity in these patients,” he added.

A test result over 225 nmol/min/mL indicates an increased risk for a cardiac event.

The FDA reviewed data from the Lp-PLA2 Activity study, a substudy from the National Institute of Health–sponsored Reasons for Geographic and Racial Differences in Stroke (REGARDS) project, which used the test in about 4,600 adults aged 45-92 years; 42% were men, 58% were women, 41.5% were black, and 58.5% were white. Over a median follow-up of 5.3 years, the rate of CHD events was 7% among those with a result that was over 225 nmol/min/mL and was about 3% among those with lower levels. Further analysis of subgroups “showed that black women experienced a higher jump in the rate of CHD events, compared with other participants when Lp-PLA2 levels were higher than 225 nmol/min/mL,” the statement said.

The manufacturer of the test is diaDexus, which defines Lp-PLA2 as a “vascular-specific inflammatory enzyme implicated in the formation of rupture-prone plaque.”

A blood test that measures a biomarker for vascular inflammation has been cleared for use as a screening test for evaluating the risk of coronary heart disease events in adults with no history of heart disease, the Food and Drug Administration announced on Dec. 15.

Studies of the PLAC Test for Lp-PLA2 Activity, which measures the activity of lipoprotein-associated phospholipase A2 (Lp-PLA2), indicate that it is more accurate in determining risk in women, particularly black women, according to the FDA’s statement. “A cardiac test that helps better predict future CHD risk in women, and especially black women, may help health care professionals identify these patients before they experience a serious CHD event, like a heart attack,” Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health, said in the statement. “We hope the clearance of this test will improve preventative care and reduce CHD-related mortality and morbidity in these patients,” he added.

A test result over 225 nmol/min/mL indicates an increased risk for a cardiac event.

The FDA reviewed data from the Lp-PLA2 Activity study, a substudy from the National Institute of Health–sponsored Reasons for Geographic and Racial Differences in Stroke (REGARDS) project, which used the test in about 4,600 adults aged 45-92 years; 42% were men, 58% were women, 41.5% were black, and 58.5% were white. Over a median follow-up of 5.3 years, the rate of CHD events was 7% among those with a result that was over 225 nmol/min/mL and was about 3% among those with lower levels. Further analysis of subgroups “showed that black women experienced a higher jump in the rate of CHD events, compared with other participants when Lp-PLA2 levels were higher than 225 nmol/min/mL,” the statement said.

The manufacturer of the test is diaDexus, which defines Lp-PLA2 as a “vascular-specific inflammatory enzyme implicated in the formation of rupture-prone plaque.”

A blood test that measures a biomarker for vascular inflammation has been cleared for use as a screening test for evaluating the risk of coronary heart disease events in adults with no history of heart disease, the Food and Drug Administration announced on Dec. 15.

Studies of the PLAC Test for Lp-PLA2 Activity, which measures the activity of lipoprotein-associated phospholipase A2 (Lp-PLA2), indicate that it is more accurate in determining risk in women, particularly black women, according to the FDA’s statement. “A cardiac test that helps better predict future CHD risk in women, and especially black women, may help health care professionals identify these patients before they experience a serious CHD event, like a heart attack,” Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health, said in the statement. “We hope the clearance of this test will improve preventative care and reduce CHD-related mortality and morbidity in these patients,” he added.

A test result over 225 nmol/min/mL indicates an increased risk for a cardiac event.

The FDA reviewed data from the Lp-PLA2 Activity study, a substudy from the National Institute of Health–sponsored Reasons for Geographic and Racial Differences in Stroke (REGARDS) project, which used the test in about 4,600 adults aged 45-92 years; 42% were men, 58% were women, 41.5% were black, and 58.5% were white. Over a median follow-up of 5.3 years, the rate of CHD events was 7% among those with a result that was over 225 nmol/min/mL and was about 3% among those with lower levels. Further analysis of subgroups “showed that black women experienced a higher jump in the rate of CHD events, compared with other participants when Lp-PLA2 levels were higher than 225 nmol/min/mL,” the statement said.

The manufacturer of the test is diaDexus, which defines Lp-PLA2 as a “vascular-specific inflammatory enzyme implicated in the formation of rupture-prone plaque.”

emechcatie@frontlinemedcom.com

A blood test that measures a biomarker for vascular inflammation has been cleared for use as a screening test for evaluating the risk of coronary heart disease events in adults with no history of heart disease, the Food and Drug Administration announced on Dec. 15.

Studies of the PLAC Test for Lp-PLA2 Activity, which measures the activity of lipoprotein-associated phospholipase A2 (Lp-PLA2), indicate that it is more accurate in determining risk in women, particularly black women, according to the FDA’s statement. “A cardiac test that helps better predict future CHD risk in women, and especially black women, may help health care professionals identify these patients before they experience a serious CHD event, like a heart attack,” Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health, said in the statement. “We hope the clearance of this test will improve preventative care and reduce CHD-related mortality and morbidity in these patients,” he added.

A test result over 225 nmol/min/mL indicates an increased risk for a cardiac event.

The FDA reviewed data from the Lp-PLA2 Activity study, a substudy from the National Institute of Health–sponsored Reasons for Geographic and Racial Differences in Stroke (REGARDS) project, which used the test in about 4,600 adults aged 45-92 years; 42% were men, 58% were women, 41.5% were black, and 58.5% were white. Over a median follow-up of 5.3 years, the rate of CHD events was 7% among those with a result that was over 225 nmol/min/mL and was about 3% among those with lower levels. Further analysis of subgroups “showed that black women experienced a higher jump in the rate of CHD events, compared with other participants when Lp-PLA2 levels were higher than 225 nmol/min/mL,” the statement said.

The manufacturer of the test is diaDexus, which defines Lp-PLA2 as a “vascular-specific inflammatory enzyme implicated in the formation of rupture-prone plaque.”

emechcatie@frontlinemedcom.com

A blood test that measures a biomarker for vascular inflammation has been cleared for use as a screening test for evaluating the risk of coronary heart disease events in adults with no history of heart disease, the Food and Drug Administration announced on Dec. 15.

Studies of the PLAC Test for Lp-PLA2 Activity, which measures the activity of lipoprotein-associated phospholipase A2 (Lp-PLA2), indicate that it is more accurate in determining risk in women, particularly black women, according to the FDA’s statement. “A cardiac test that helps better predict future CHD risk in women, and especially black women, may help health care professionals identify these patients before they experience a serious CHD event, like a heart attack,” Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health, said in the statement. “We hope the clearance of this test will improve preventative care and reduce CHD-related mortality and morbidity in these patients,” he added.

A test result over 225 nmol/min/mL indicates an increased risk for a cardiac event.

The FDA reviewed data from the Lp-PLA2 Activity study, a substudy from the National Institute of Health–sponsored Reasons for Geographic and Racial Differences in Stroke (REGARDS) project, which used the test in about 4,600 adults aged 45-92 years; 42% were men, 58% were women, 41.5% were black, and 58.5% were white. Over a median follow-up of 5.3 years, the rate of CHD events was 7% among those with a result that was over 225 nmol/min/mL and was about 3% among those with lower levels. Further analysis of subgroups “showed that black women experienced a higher jump in the rate of CHD events, compared with other participants when Lp-PLA2 levels were higher than 225 nmol/min/mL,” the statement said.

The manufacturer of the test is diaDexus, which defines Lp-PLA2 as a “vascular-specific inflammatory enzyme implicated in the formation of rupture-prone plaque.”

emechcatie@frontlinemedcom.com

A screening test for syphilis that can produce results in 12 minutes has been granted a waiver, allowing it “to be used in a greater variety of health care settings,” including physician’s offices, the Food and Drug Administration announced on Dec. 15.

The Syphilis Health Check test, which uses a finger stick blood sample, was granted a waiver under the Clinical Laboratory Improvement Amendments (CLIA) to allow it to be used outside of traditional laboratory settings. The approval was based on data “demonstrating the test’s ease of use and accuracy,” according to the statement. Other settings in which it can now be used include emergency departments, maternity wards, health department clinics, and community-based organizations and testing sites.

Health care workers without special training will be allowed to perform the test, the FDA said.

When the test was initially approved in 2011, it was categorized as “moderate and high complexity” under CLIA. The current waiver was granted based on data submitted by the manufacturer. Over 4 months, the test was used in 417 people at sites that have CLIA waivers, which included physician offices. The people performing the test were not trained, and the results were highly accurate.

If the test is positive, another blood sample should be obtained during the same visit and sent to a lab for serologic testing, and patients should be further evaluated before a final diagnosis is made, the FDA advised.

“The broader availability and easier access to this test should contribute to a higher rate of detection of syphilis infection,” Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health, said in the statement.

About 55,000 people in the United States become infected with syphilis every year, and 75% of the primary and secondary syphilis cases in 2012 were among men who have sex with men, according to estimates from the Centers for Disease Control and Prevention.

The test is manufactured by a French company, VEDA LAB, for Diagnostics Direct, LLC, which is based in the United States.

emechcatie@frontlinemedcom.com

A screening test for syphilis that can produce results in 12 minutes has been granted a waiver, allowing it “to be used in a greater variety of health care settings,” including physician’s offices, the Food and Drug Administration announced on Dec. 15.

The Syphilis Health Check test, which uses a finger stick blood sample, was granted a waiver under the Clinical Laboratory Improvement Amendments (CLIA) to allow it to be used outside of traditional laboratory settings. The approval was based on data “demonstrating the test’s ease of use and accuracy,” according to the statement. Other settings in which it can now be used include emergency departments, maternity wards, health department clinics, and community-based organizations and testing sites.

Health care workers without special training will be allowed to perform the test, the FDA said.

When the test was initially approved in 2011, it was categorized as “moderate and high complexity” under CLIA. The current waiver was granted based on data submitted by the manufacturer. Over 4 months, the test was used in 417 people at sites that have CLIA waivers, which included physician offices. The people performing the test were not trained, and the results were highly accurate.

If the test is positive, another blood sample should be obtained during the same visit and sent to a lab for serologic testing, and patients should be further evaluated before a final diagnosis is made, the FDA advised.

“The broader availability and easier access to this test should contribute to a higher rate of detection of syphilis infection,” Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health, said in the statement.

About 55,000 people in the United States become infected with syphilis every year, and 75% of the primary and secondary syphilis cases in 2012 were among men who have sex with men, according to estimates from the Centers for Disease Control and Prevention.

The test is manufactured by a French company, VEDA LAB, for Diagnostics Direct, LLC, which is based in the United States.

emechcatie@frontlinemedcom.com

A screening test for syphilis that can produce results in 12 minutes has been granted a waiver, allowing it “to be used in a greater variety of health care settings,” including physician’s offices, the Food and Drug Administration announced on Dec. 15.

The Syphilis Health Check test, which uses a finger stick blood sample, was granted a waiver under the Clinical Laboratory Improvement Amendments (CLIA) to allow it to be used outside of traditional laboratory settings. The approval was based on data “demonstrating the test’s ease of use and accuracy,” according to the statement. Other settings in which it can now be used include emergency departments, maternity wards, health department clinics, and community-based organizations and testing sites.

Health care workers without special training will be allowed to perform the test, the FDA said.

When the test was initially approved in 2011, it was categorized as “moderate and high complexity” under CLIA. The current waiver was granted based on data submitted by the manufacturer. Over 4 months, the test was used in 417 people at sites that have CLIA waivers, which included physician offices. The people performing the test were not trained, and the results were highly accurate.

If the test is positive, another blood sample should be obtained during the same visit and sent to a lab for serologic testing, and patients should be further evaluated before a final diagnosis is made, the FDA advised.

“The broader availability and easier access to this test should contribute to a higher rate of detection of syphilis infection,” Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health, said in the statement.

About 55,000 people in the United States become infected with syphilis every year, and 75% of the primary and secondary syphilis cases in 2012 were among men who have sex with men, according to estimates from the Centers for Disease Control and Prevention.

The test is manufactured by a French company, VEDA LAB, for Diagnostics Direct, LLC, which is based in the United States.

emechcatie@frontlinemedcom.com

Ramucirumab, a vascular endothelial growth factor receptor 2 antagonist, has been approved for treating aggressive non-small cell lung cancer, the third indication approved for the agent in 2014, the Food and Drug Administration announced Dec. 12.

The approved indication is for ramucirumab, in combination with docetaxel, for “the treatment of metastatic non–small cell lung cancer with disease progression on or after platinum-based chemotherapy,” according to the updated prescribing information. The indication includes the statement that “patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations” before they are treated with ramucirumab.

Ramucirumab, marketed as Cyramza by Eli Lilly, was initially approved in April as a treatment for patients with advanced gastric cancer or gastroesophageal junction (GEJ) adenocarcinoma, as a single agent after prior fluoropyrimidine or platinum-containing therapy. In November, it was approved in combination with paclitaxel, as a treatment for patients with advanced gastric or GEJ adenocarcinoma, with disease progression on or after prior fluoropyrimidine or platinum-containing chemotherapy.

“The commitment to study [ramucirumab] in a variety of malignancies provides important treatment options to patients,” Dr. Richard Pazdur, director of the office of hematology and oncology products in the FDA Center for Drug Evaluation and Research said in a statement.

The latest indication was approved based on a multicenter, double-blind, placebo-controlled study of 1,253 people with previously treated metastatic NSCLC, randomized to treatment with ramucirumab plus docetaxel or docetaxel plus placebo, administered until disease progressed or they developed intolerable adverse effects. Median overall survival among those treated with ramucirumab was 10.5 months vs. 9.1 months among those on docetaxel alone, a statistically significant difference (hazard ratio, 0.86, P = .024). In addition, progression-free survival was significantly longer (P less than .001), according to the FDA.

Neutropenia, stomatitis, and fatigue were among the most common adverse events associated with treatment. The drug’s label included a boxed warning about the increased risk of hemorrhage, including severe and sometimes fatal hemorrhagic events, associated with treatment.

The recommended dosing for the NSCLC indication is ramucirumab (10 mg/kg intravenously) and docetaxel (75 mg/m² IV) administered every 3 weeks.

NSCLC is the most common type of lung cancer and will be diagnosed in 224,210 people in the United States in 2014, according to National Cancer Institute estimates cited in the FDA statement.

Serious adverse events associated with ramucirumab and any other medication or device should be reported to the FDA’s MedWatch program at 800-332-1088 or www.fda.gov/medwatch/report.htm.

emechcatie@frontlinemedcom.com

Ramucirumab, a vascular endothelial growth factor receptor 2 antagonist, has been approved for treating aggressive non-small cell lung cancer, the third indication approved for the agent in 2014, the Food and Drug Administration announced Dec. 12.

The approved indication is for ramucirumab, in combination with docetaxel, for “the treatment of metastatic non–small cell lung cancer with disease progression on or after platinum-based chemotherapy,” according to the updated prescribing information. The indication includes the statement that “patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations” before they are treated with ramucirumab.

Ramucirumab, marketed as Cyramza by Eli Lilly, was initially approved in April as a treatment for patients with advanced gastric cancer or gastroesophageal junction (GEJ) adenocarcinoma, as a single agent after prior fluoropyrimidine or platinum-containing therapy. In November, it was approved in combination with paclitaxel, as a treatment for patients with advanced gastric or GEJ adenocarcinoma, with disease progression on or after prior fluoropyrimidine or platinum-containing chemotherapy.

“The commitment to study [ramucirumab] in a variety of malignancies provides important treatment options to patients,” Dr. Richard Pazdur, director of the office of hematology and oncology products in the FDA Center for Drug Evaluation and Research said in a statement.

The latest indication was approved based on a multicenter, double-blind, placebo-controlled study of 1,253 people with previously treated metastatic NSCLC, randomized to treatment with ramucirumab plus docetaxel or docetaxel plus placebo, administered until disease progressed or they developed intolerable adverse effects. Median overall survival among those treated with ramucirumab was 10.5 months vs. 9.1 months among those on docetaxel alone, a statistically significant difference (hazard ratio, 0.86, P = .024). In addition, progression-free survival was significantly longer (P less than .001), according to the FDA.

Neutropenia, stomatitis, and fatigue were among the most common adverse events associated with treatment. The drug’s label included a boxed warning about the increased risk of hemorrhage, including severe and sometimes fatal hemorrhagic events, associated with treatment.

The recommended dosing for the NSCLC indication is ramucirumab (10 mg/kg intravenously) and docetaxel (75 mg/m² IV) administered every 3 weeks.

NSCLC is the most common type of lung cancer and will be diagnosed in 224,210 people in the United States in 2014, according to National Cancer Institute estimates cited in the FDA statement.

Serious adverse events associated with ramucirumab and any other medication or device should be reported to the FDA’s MedWatch program at 800-332-1088 or www.fda.gov/medwatch/report.htm.

emechcatie@frontlinemedcom.com

Ramucirumab, a vascular endothelial growth factor receptor 2 antagonist, has been approved for treating aggressive non-small cell lung cancer, the third indication approved for the agent in 2014, the Food and Drug Administration announced Dec. 12.

The approved indication is for ramucirumab, in combination with docetaxel, for “the treatment of metastatic non–small cell lung cancer with disease progression on or after platinum-based chemotherapy,” according to the updated prescribing information. The indication includes the statement that “patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations” before they are treated with ramucirumab.

Ramucirumab, marketed as Cyramza by Eli Lilly, was initially approved in April as a treatment for patients with advanced gastric cancer or gastroesophageal junction (GEJ) adenocarcinoma, as a single agent after prior fluoropyrimidine or platinum-containing therapy. In November, it was approved in combination with paclitaxel, as a treatment for patients with advanced gastric or GEJ adenocarcinoma, with disease progression on or after prior fluoropyrimidine or platinum-containing chemotherapy.

“The commitment to study [ramucirumab] in a variety of malignancies provides important treatment options to patients,” Dr. Richard Pazdur, director of the office of hematology and oncology products in the FDA Center for Drug Evaluation and Research said in a statement.

The latest indication was approved based on a multicenter, double-blind, placebo-controlled study of 1,253 people with previously treated metastatic NSCLC, randomized to treatment with ramucirumab plus docetaxel or docetaxel plus placebo, administered until disease progressed or they developed intolerable adverse effects. Median overall survival among those treated with ramucirumab was 10.5 months vs. 9.1 months among those on docetaxel alone, a statistically significant difference (hazard ratio, 0.86, P = .024). In addition, progression-free survival was significantly longer (P less than .001), according to the FDA.

Neutropenia, stomatitis, and fatigue were among the most common adverse events associated with treatment. The drug’s label included a boxed warning about the increased risk of hemorrhage, including severe and sometimes fatal hemorrhagic events, associated with treatment.

The recommended dosing for the NSCLC indication is ramucirumab (10 mg/kg intravenously) and docetaxel (75 mg/m² IV) administered every 3 weeks.

NSCLC is the most common type of lung cancer and will be diagnosed in 224,210 people in the United States in 2014, according to National Cancer Institute estimates cited in the FDA statement.

Serious adverse events associated with ramucirumab and any other medication or device should be reported to the FDA’s MedWatch program at 800-332-1088 or www.fda.gov/medwatch/report.htm.

emechcatie@frontlinemedcom.com