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Cotempla XR-ODT approved for children, adolescents with ADHD
The Food and Drug Administration has approved the first methylphenidate extended-release orally disintegrating tablet for treating ADHD in patients aged 6-17 years old, Neos Therapeutics announced June 19.
The company said the approval came after a phase III trial showed that treatment in a laboratory classroom with the drug, called Cotempla XR-ODT, showed a significant improvement in attention-deficit/hyperactivity disorder symptom control when compared with a placebo across the classroom day (placebo-subtracted difference of –11). The onset of effect was shown at 1 hour post-dose and lasted through 12 hours. No serious adverse events were reported during the trial, and the adverse event profile was consistent with the established safety profile for other extended-release methylphenidate products.
Cotempla XR-ODT will be available commercially in a portable, child-resistant blister pack in the fall of 2017.
Find the full press release on Neos Therapeutics website.
The Food and Drug Administration has approved the first methylphenidate extended-release orally disintegrating tablet for treating ADHD in patients aged 6-17 years old, Neos Therapeutics announced June 19.
The company said the approval came after a phase III trial showed that treatment in a laboratory classroom with the drug, called Cotempla XR-ODT, showed a significant improvement in attention-deficit/hyperactivity disorder symptom control when compared with a placebo across the classroom day (placebo-subtracted difference of –11). The onset of effect was shown at 1 hour post-dose and lasted through 12 hours. No serious adverse events were reported during the trial, and the adverse event profile was consistent with the established safety profile for other extended-release methylphenidate products.
Cotempla XR-ODT will be available commercially in a portable, child-resistant blister pack in the fall of 2017.
Find the full press release on Neos Therapeutics website.
The Food and Drug Administration has approved the first methylphenidate extended-release orally disintegrating tablet for treating ADHD in patients aged 6-17 years old, Neos Therapeutics announced June 19.
The company said the approval came after a phase III trial showed that treatment in a laboratory classroom with the drug, called Cotempla XR-ODT, showed a significant improvement in attention-deficit/hyperactivity disorder symptom control when compared with a placebo across the classroom day (placebo-subtracted difference of –11). The onset of effect was shown at 1 hour post-dose and lasted through 12 hours. No serious adverse events were reported during the trial, and the adverse event profile was consistent with the established safety profile for other extended-release methylphenidate products.
Cotempla XR-ODT will be available commercially in a portable, child-resistant blister pack in the fall of 2017.
Find the full press release on Neos Therapeutics website.
FDA advisory committee supports new CV liraglutide indication
A Food and Drug Administration advisory committee voted 17-2 in support of a supplemental new drug application for liraglutide (Victoza) injections to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes and established cardiovascular disease.
Novo Nordisk, the maker of the glucagon-like peptide-1 (GLP-1) analogue, proposed the additional indication for liraglutide as an adjunct to standard treatment of cardiovascular risk factors in such patients based solely on the results of the randomized, placebo-controlled postmarketing LEADER trial.
If this additional indication for liraglutide is approved by the FDA, the drug would join the antidiabetic drug empagliflozin (Jardiance) in having a second indication for the reduction of the risk of cardiovascular death. The supplemental new drug application for Jardiance was approved by the FDA in December 2016 – also based on the results of a single trial (the EMPA-REG outcomes trial). Of note, the American Diabetes Association in its 2017 Standards of Medical Care has already called for consideration of both liraglutide and empagliflozin to reduce the risk of cardiovascular death in patients with type 2 diabetes and documented cardiovascular disease.
Liraglutide is currently approved for blood glucose lowering in adults with type 2 diabetes and is marketed as Saxenda for the treatment of overweight and obese adults with at least one weight-related comorbidity. It was shown in the LEADER trial to be associated with a significant 13% lower risk vs. placebo for a composite outcome of death from cardiovascular causes, nonfatal myocardial infarction, and nonfatal stroke in patients with type 2 diabetes.
All 19 voting members of the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) agreed that the LEADER results confirm there is no excess cardiovascular risk associated with liraglutide in patients with type 2 diabetes, but, on the question of whether the results provide “the substantial evidence required to establish that liraglutide 1.8 mg reduces cardiovascular risk in patients with type 2 diabetes mellitus and established cardiovascular disease,” almost all voting members expressed concerns about subgroup analyses showing reduced benefit among U.S. patients, compared with those from other countries.
“I think probably the most influential finding for me was the overall cardiovascular mortality finding, followed by the consistency of the results,” said biostatistics expert James D. Neaton, PhD, of the University of Minnesota, Minneapolis. He added that the indication should focus on patients at high cardiovascular event risk, as the LEADER population was a very high risk group.
Similarly, temporary voting member Marvin A. Konstam, MD, of Tufts University, Boston, said “the primary trial results are very robust and substantiated.
“And I think the cardiovascular mortality is the biggest contributor to that, which is obviously a very important finding,” he said, also stressing that the indication should focus on patients with established cardiovascular disease.
“I am concerned about the U.S. population, but at the end of the day, it’s a subgroup, and I just can’t overrate that to diminish the overall finding,” he added.
Peter W.F. Wilson, MD, EMDAC chairperson, said he “wrestles with exactly who benefits the most because of overlapping of some of the groupings.
“But people who really have atherosclerotic cardiovascular disease ... are probably the people who will benefit the most, and I hope those are the people who will get it,” said Dr. Wilson, professor of medicine at Emory University, professor of public health at Rollins School of Public Health, and director of epidemiology and genomic medicine at the Atlanta VA Medical Center.
In explaining his “no” vote, Daniel Budnitz, MD, of the Centers for Disease Control and Prevention, Atlanta, said his was a tough decision, but that ultimately, since the U.S. population is the one the FDA is addressing with its labeling, the subgroup concerns weighed heavily.
“And I do worry about a slippery slope of using single-trial data for new indications, when there are questions and when you do have an interaction term for the U.S. vs. the rest of the world,” he said, adding that he would like to see either another international trial where the United States population does not differ from the rest of the world, or a U.S. trial.
Carmen J. Allegra, MD, of the University of Florida, Gainesville, also voted no, and said he, too, was concerned by the subgroup analysis.
“I was very much concerned and swayed by the subgroup analysis. The U.S. target population is a pretty darn important population for us to consider, and we saw a significant interaction with outcomes vs. the region by the FDA’s analysis,” he said. “I was really swayed by the fact that we really didn’t see evidence of superiority in the U.S. population.”
The LEADER trial, which was designed in accordance with FDA Guidance issued in 2008 to demonstrate that new antidiabetes drugs do not result in unacceptably increased cardiovascular risk, included 9,340 patients who were randomized to receive liraglutide or placebo as add-on to standard of care treatment and who were followed for a median of 3.8 years. Those randomized to receive liraglutide experienced significantly lower risk of the composite primary outcome (hazard ratio, 0.87), Notably, the effect was diminished among U.S. patients, compared with the overall benefit.
However, after hearing LEADER analyses from Novo Nordisk representatives and FDA representatives, and testimony from numerous individuals, including patients, physicians, and patient advocates who spoke overwhelmingly in favor of approval of the supplemental drug application, the committee recommended that approval.
“This was not a slam dunk. I think the subgroup analysis was interesting discussion, but in the end you have to take the data and the primary outcome measure as what you move on,” said temporary voting member David C. Robbins, MD, of the University of Kansas, Kansas City, adding that “the good is outweighing the bad on this.
“I’m glad to see diabetes management moving toward more than lowering blood sugar. It’s a good step in the right direction,” he said.
The FDA, which usually follows the recommendations of its advisory committees, will now consider the supplemental new drug application for liraglutide.
In a statement released after the vote, Todd Hobbs, MD, vice president and U.S. chief medical officer of Novo Nordisk, noted that cardiovascular disease remains the leading cause of death for people with type 2 diabetes. The discussion during the EMDAC meeting is “an important reminder that there is an unmet need to provide benefits beyond HbA1c control” in patients with type 2 diabetes.
EMDAC committee members were screened and found to be in compliance with federal ethics and conflict of interest laws; one (Dr. Konstam) was granted a waiver in accordance with rules allowing such waivers when the need for an individual’s service outweighs any potential financial conflicts of interest. Dr. Konstam reported financial relationships with competing firms.
A Food and Drug Administration advisory committee voted 17-2 in support of a supplemental new drug application for liraglutide (Victoza) injections to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes and established cardiovascular disease.
Novo Nordisk, the maker of the glucagon-like peptide-1 (GLP-1) analogue, proposed the additional indication for liraglutide as an adjunct to standard treatment of cardiovascular risk factors in such patients based solely on the results of the randomized, placebo-controlled postmarketing LEADER trial.
If this additional indication for liraglutide is approved by the FDA, the drug would join the antidiabetic drug empagliflozin (Jardiance) in having a second indication for the reduction of the risk of cardiovascular death. The supplemental new drug application for Jardiance was approved by the FDA in December 2016 – also based on the results of a single trial (the EMPA-REG outcomes trial). Of note, the American Diabetes Association in its 2017 Standards of Medical Care has already called for consideration of both liraglutide and empagliflozin to reduce the risk of cardiovascular death in patients with type 2 diabetes and documented cardiovascular disease.
Liraglutide is currently approved for blood glucose lowering in adults with type 2 diabetes and is marketed as Saxenda for the treatment of overweight and obese adults with at least one weight-related comorbidity. It was shown in the LEADER trial to be associated with a significant 13% lower risk vs. placebo for a composite outcome of death from cardiovascular causes, nonfatal myocardial infarction, and nonfatal stroke in patients with type 2 diabetes.
All 19 voting members of the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) agreed that the LEADER results confirm there is no excess cardiovascular risk associated with liraglutide in patients with type 2 diabetes, but, on the question of whether the results provide “the substantial evidence required to establish that liraglutide 1.8 mg reduces cardiovascular risk in patients with type 2 diabetes mellitus and established cardiovascular disease,” almost all voting members expressed concerns about subgroup analyses showing reduced benefit among U.S. patients, compared with those from other countries.
“I think probably the most influential finding for me was the overall cardiovascular mortality finding, followed by the consistency of the results,” said biostatistics expert James D. Neaton, PhD, of the University of Minnesota, Minneapolis. He added that the indication should focus on patients at high cardiovascular event risk, as the LEADER population was a very high risk group.
Similarly, temporary voting member Marvin A. Konstam, MD, of Tufts University, Boston, said “the primary trial results are very robust and substantiated.
“And I think the cardiovascular mortality is the biggest contributor to that, which is obviously a very important finding,” he said, also stressing that the indication should focus on patients with established cardiovascular disease.
“I am concerned about the U.S. population, but at the end of the day, it’s a subgroup, and I just can’t overrate that to diminish the overall finding,” he added.
Peter W.F. Wilson, MD, EMDAC chairperson, said he “wrestles with exactly who benefits the most because of overlapping of some of the groupings.
“But people who really have atherosclerotic cardiovascular disease ... are probably the people who will benefit the most, and I hope those are the people who will get it,” said Dr. Wilson, professor of medicine at Emory University, professor of public health at Rollins School of Public Health, and director of epidemiology and genomic medicine at the Atlanta VA Medical Center.
In explaining his “no” vote, Daniel Budnitz, MD, of the Centers for Disease Control and Prevention, Atlanta, said his was a tough decision, but that ultimately, since the U.S. population is the one the FDA is addressing with its labeling, the subgroup concerns weighed heavily.
“And I do worry about a slippery slope of using single-trial data for new indications, when there are questions and when you do have an interaction term for the U.S. vs. the rest of the world,” he said, adding that he would like to see either another international trial where the United States population does not differ from the rest of the world, or a U.S. trial.
Carmen J. Allegra, MD, of the University of Florida, Gainesville, also voted no, and said he, too, was concerned by the subgroup analysis.
“I was very much concerned and swayed by the subgroup analysis. The U.S. target population is a pretty darn important population for us to consider, and we saw a significant interaction with outcomes vs. the region by the FDA’s analysis,” he said. “I was really swayed by the fact that we really didn’t see evidence of superiority in the U.S. population.”
The LEADER trial, which was designed in accordance with FDA Guidance issued in 2008 to demonstrate that new antidiabetes drugs do not result in unacceptably increased cardiovascular risk, included 9,340 patients who were randomized to receive liraglutide or placebo as add-on to standard of care treatment and who were followed for a median of 3.8 years. Those randomized to receive liraglutide experienced significantly lower risk of the composite primary outcome (hazard ratio, 0.87), Notably, the effect was diminished among U.S. patients, compared with the overall benefit.
However, after hearing LEADER analyses from Novo Nordisk representatives and FDA representatives, and testimony from numerous individuals, including patients, physicians, and patient advocates who spoke overwhelmingly in favor of approval of the supplemental drug application, the committee recommended that approval.
“This was not a slam dunk. I think the subgroup analysis was interesting discussion, but in the end you have to take the data and the primary outcome measure as what you move on,” said temporary voting member David C. Robbins, MD, of the University of Kansas, Kansas City, adding that “the good is outweighing the bad on this.
“I’m glad to see diabetes management moving toward more than lowering blood sugar. It’s a good step in the right direction,” he said.
The FDA, which usually follows the recommendations of its advisory committees, will now consider the supplemental new drug application for liraglutide.
In a statement released after the vote, Todd Hobbs, MD, vice president and U.S. chief medical officer of Novo Nordisk, noted that cardiovascular disease remains the leading cause of death for people with type 2 diabetes. The discussion during the EMDAC meeting is “an important reminder that there is an unmet need to provide benefits beyond HbA1c control” in patients with type 2 diabetes.
EMDAC committee members were screened and found to be in compliance with federal ethics and conflict of interest laws; one (Dr. Konstam) was granted a waiver in accordance with rules allowing such waivers when the need for an individual’s service outweighs any potential financial conflicts of interest. Dr. Konstam reported financial relationships with competing firms.
A Food and Drug Administration advisory committee voted 17-2 in support of a supplemental new drug application for liraglutide (Victoza) injections to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes and established cardiovascular disease.
Novo Nordisk, the maker of the glucagon-like peptide-1 (GLP-1) analogue, proposed the additional indication for liraglutide as an adjunct to standard treatment of cardiovascular risk factors in such patients based solely on the results of the randomized, placebo-controlled postmarketing LEADER trial.
If this additional indication for liraglutide is approved by the FDA, the drug would join the antidiabetic drug empagliflozin (Jardiance) in having a second indication for the reduction of the risk of cardiovascular death. The supplemental new drug application for Jardiance was approved by the FDA in December 2016 – also based on the results of a single trial (the EMPA-REG outcomes trial). Of note, the American Diabetes Association in its 2017 Standards of Medical Care has already called for consideration of both liraglutide and empagliflozin to reduce the risk of cardiovascular death in patients with type 2 diabetes and documented cardiovascular disease.
Liraglutide is currently approved for blood glucose lowering in adults with type 2 diabetes and is marketed as Saxenda for the treatment of overweight and obese adults with at least one weight-related comorbidity. It was shown in the LEADER trial to be associated with a significant 13% lower risk vs. placebo for a composite outcome of death from cardiovascular causes, nonfatal myocardial infarction, and nonfatal stroke in patients with type 2 diabetes.
All 19 voting members of the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) agreed that the LEADER results confirm there is no excess cardiovascular risk associated with liraglutide in patients with type 2 diabetes, but, on the question of whether the results provide “the substantial evidence required to establish that liraglutide 1.8 mg reduces cardiovascular risk in patients with type 2 diabetes mellitus and established cardiovascular disease,” almost all voting members expressed concerns about subgroup analyses showing reduced benefit among U.S. patients, compared with those from other countries.
“I think probably the most influential finding for me was the overall cardiovascular mortality finding, followed by the consistency of the results,” said biostatistics expert James D. Neaton, PhD, of the University of Minnesota, Minneapolis. He added that the indication should focus on patients at high cardiovascular event risk, as the LEADER population was a very high risk group.
Similarly, temporary voting member Marvin A. Konstam, MD, of Tufts University, Boston, said “the primary trial results are very robust and substantiated.
“And I think the cardiovascular mortality is the biggest contributor to that, which is obviously a very important finding,” he said, also stressing that the indication should focus on patients with established cardiovascular disease.
“I am concerned about the U.S. population, but at the end of the day, it’s a subgroup, and I just can’t overrate that to diminish the overall finding,” he added.
Peter W.F. Wilson, MD, EMDAC chairperson, said he “wrestles with exactly who benefits the most because of overlapping of some of the groupings.
“But people who really have atherosclerotic cardiovascular disease ... are probably the people who will benefit the most, and I hope those are the people who will get it,” said Dr. Wilson, professor of medicine at Emory University, professor of public health at Rollins School of Public Health, and director of epidemiology and genomic medicine at the Atlanta VA Medical Center.
In explaining his “no” vote, Daniel Budnitz, MD, of the Centers for Disease Control and Prevention, Atlanta, said his was a tough decision, but that ultimately, since the U.S. population is the one the FDA is addressing with its labeling, the subgroup concerns weighed heavily.
“And I do worry about a slippery slope of using single-trial data for new indications, when there are questions and when you do have an interaction term for the U.S. vs. the rest of the world,” he said, adding that he would like to see either another international trial where the United States population does not differ from the rest of the world, or a U.S. trial.
Carmen J. Allegra, MD, of the University of Florida, Gainesville, also voted no, and said he, too, was concerned by the subgroup analysis.
“I was very much concerned and swayed by the subgroup analysis. The U.S. target population is a pretty darn important population for us to consider, and we saw a significant interaction with outcomes vs. the region by the FDA’s analysis,” he said. “I was really swayed by the fact that we really didn’t see evidence of superiority in the U.S. population.”
The LEADER trial, which was designed in accordance with FDA Guidance issued in 2008 to demonstrate that new antidiabetes drugs do not result in unacceptably increased cardiovascular risk, included 9,340 patients who were randomized to receive liraglutide or placebo as add-on to standard of care treatment and who were followed for a median of 3.8 years. Those randomized to receive liraglutide experienced significantly lower risk of the composite primary outcome (hazard ratio, 0.87), Notably, the effect was diminished among U.S. patients, compared with the overall benefit.
However, after hearing LEADER analyses from Novo Nordisk representatives and FDA representatives, and testimony from numerous individuals, including patients, physicians, and patient advocates who spoke overwhelmingly in favor of approval of the supplemental drug application, the committee recommended that approval.
“This was not a slam dunk. I think the subgroup analysis was interesting discussion, but in the end you have to take the data and the primary outcome measure as what you move on,” said temporary voting member David C. Robbins, MD, of the University of Kansas, Kansas City, adding that “the good is outweighing the bad on this.
“I’m glad to see diabetes management moving toward more than lowering blood sugar. It’s a good step in the right direction,” he said.
The FDA, which usually follows the recommendations of its advisory committees, will now consider the supplemental new drug application for liraglutide.
In a statement released after the vote, Todd Hobbs, MD, vice president and U.S. chief medical officer of Novo Nordisk, noted that cardiovascular disease remains the leading cause of death for people with type 2 diabetes. The discussion during the EMDAC meeting is “an important reminder that there is an unmet need to provide benefits beyond HbA1c control” in patients with type 2 diabetes.
EMDAC committee members were screened and found to be in compliance with federal ethics and conflict of interest laws; one (Dr. Konstam) was granted a waiver in accordance with rules allowing such waivers when the need for an individual’s service outweighs any potential financial conflicts of interest. Dr. Konstam reported financial relationships with competing firms.
Mydayis approved for teens, adults with ADHD
The Food and Drug Administration has approved a once-a-day treatment for patients aged 13 years and older with ADHD, Shire announced June 20 in a press release.
The approval of Mydayis was based on results from 16 clinical studies evaluating the medication in more than 1,600 adolescents (aged 13-17 years) and adults with attention-deficit/hyperactivity disorder. In the placebo-controlled clinical studies, Mydayis significantly improved symptoms of ADHD, as measured by the ADHD-RS-IV and the Permanent Product Measure of Performance (PERMP), in adults and adolescents. Improvement on the PERMP reached statistical significance beginning at 2 or 4 hours post dose and lasting up to 16 hours post dose.
The medication, an amphetamine product, consists of three different types of drug-releasing beads.
“With this approval, we hope to help patients who need a once-daily treatment option,” Flemming Ornskov, MD, MPH, said in a press release. Dr. Ornskov is CEO of Shire.
It is estimated that 4.4% of adults have ADHD in the United States, and 50%-66% of children with ADHD may continue to have symptoms of the disorder as adults.
Mydayis will be commercially available in the United States in the third quarter of 2017.
Read the full press release here.
The Food and Drug Administration has approved a once-a-day treatment for patients aged 13 years and older with ADHD, Shire announced June 20 in a press release.
The approval of Mydayis was based on results from 16 clinical studies evaluating the medication in more than 1,600 adolescents (aged 13-17 years) and adults with attention-deficit/hyperactivity disorder. In the placebo-controlled clinical studies, Mydayis significantly improved symptoms of ADHD, as measured by the ADHD-RS-IV and the Permanent Product Measure of Performance (PERMP), in adults and adolescents. Improvement on the PERMP reached statistical significance beginning at 2 or 4 hours post dose and lasting up to 16 hours post dose.
The medication, an amphetamine product, consists of three different types of drug-releasing beads.
“With this approval, we hope to help patients who need a once-daily treatment option,” Flemming Ornskov, MD, MPH, said in a press release. Dr. Ornskov is CEO of Shire.
It is estimated that 4.4% of adults have ADHD in the United States, and 50%-66% of children with ADHD may continue to have symptoms of the disorder as adults.
Mydayis will be commercially available in the United States in the third quarter of 2017.
Read the full press release here.
The Food and Drug Administration has approved a once-a-day treatment for patients aged 13 years and older with ADHD, Shire announced June 20 in a press release.
The approval of Mydayis was based on results from 16 clinical studies evaluating the medication in more than 1,600 adolescents (aged 13-17 years) and adults with attention-deficit/hyperactivity disorder. In the placebo-controlled clinical studies, Mydayis significantly improved symptoms of ADHD, as measured by the ADHD-RS-IV and the Permanent Product Measure of Performance (PERMP), in adults and adolescents. Improvement on the PERMP reached statistical significance beginning at 2 or 4 hours post dose and lasting up to 16 hours post dose.
The medication, an amphetamine product, consists of three different types of drug-releasing beads.
“With this approval, we hope to help patients who need a once-daily treatment option,” Flemming Ornskov, MD, MPH, said in a press release. Dr. Ornskov is CEO of Shire.
It is estimated that 4.4% of adults have ADHD in the United States, and 50%-66% of children with ADHD may continue to have symptoms of the disorder as adults.
Mydayis will be commercially available in the United States in the third quarter of 2017.
Read the full press release here.
FDA approves new fluoroquinolone for skin, skin structure infections
The Food and Drug Administration has approved delafloxacin, a fluoroquinolone, for the treatment of acute bacterial skin and skin structure infections, according to an agency announcement June 19.
Delafloxacin, which will be marketed by Melinta Therapeutics as Baxdela, was designated a qualified infectious disease product (QIDP) and granted fast-track and priority review. These classifications are designed to speed approval of antibacterial products to treat serious or life-threatening infections, according to an FDA statement.
Common adverse events seen with use of delafloxacin included nausea, diarrhea, headache, elevated liver enzymes, and vomiting.
The approval requires Melinta Therapeutics to conduct a 5-year postmarketing surveillance study to look for resistance to delafloxacin; the final report on that study must be submitted by the end of 2022.
The drug was not subject to FDA advisory committee review because its new drug application “did not raise significant safety or efficacy issues that were unexpected” for a drug in its class, according to FDA officials.
For more information see the Drugs@FDA listing for Baxdela.
dfulton@frontlinemedcom.com
On Twitter @denisefulton
The Food and Drug Administration has approved delafloxacin, a fluoroquinolone, for the treatment of acute bacterial skin and skin structure infections, according to an agency announcement June 19.
Delafloxacin, which will be marketed by Melinta Therapeutics as Baxdela, was designated a qualified infectious disease product (QIDP) and granted fast-track and priority review. These classifications are designed to speed approval of antibacterial products to treat serious or life-threatening infections, according to an FDA statement.
Common adverse events seen with use of delafloxacin included nausea, diarrhea, headache, elevated liver enzymes, and vomiting.
The approval requires Melinta Therapeutics to conduct a 5-year postmarketing surveillance study to look for resistance to delafloxacin; the final report on that study must be submitted by the end of 2022.
The drug was not subject to FDA advisory committee review because its new drug application “did not raise significant safety or efficacy issues that were unexpected” for a drug in its class, according to FDA officials.
For more information see the Drugs@FDA listing for Baxdela.
dfulton@frontlinemedcom.com
On Twitter @denisefulton
The Food and Drug Administration has approved delafloxacin, a fluoroquinolone, for the treatment of acute bacterial skin and skin structure infections, according to an agency announcement June 19.
Delafloxacin, which will be marketed by Melinta Therapeutics as Baxdela, was designated a qualified infectious disease product (QIDP) and granted fast-track and priority review. These classifications are designed to speed approval of antibacterial products to treat serious or life-threatening infections, according to an FDA statement.
Common adverse events seen with use of delafloxacin included nausea, diarrhea, headache, elevated liver enzymes, and vomiting.
The approval requires Melinta Therapeutics to conduct a 5-year postmarketing surveillance study to look for resistance to delafloxacin; the final report on that study must be submitted by the end of 2022.
The drug was not subject to FDA advisory committee review because its new drug application “did not raise significant safety or efficacy issues that were unexpected” for a drug in its class, according to FDA officials.
For more information see the Drugs@FDA listing for Baxdela.
dfulton@frontlinemedcom.com
On Twitter @denisefulton
BMS recalls a lot of Eliquis 5 mg tablets
Bristol-Myers Squibb is recalling one lot of Eliquis (apixaban) tablets, according to a company announcement on the Food and Drug Administration website.
The recall is based on a customer complaint that a bottle labeled as containing 5 mg tablets of Eliquis actually contained 2.5 mg tablets of Eliquis. The lot in question was distributed nationwide to wholesalers and retail pharmacies in February 2017. The recall is voluntary, the company noted.
“There are distinct visible differences between the two tablet strengths, including colors, size, and markings that distinguish the 2.5 mg and 5 mg tablets and decrease the likelihood of an incorrect dose,” Bristol-Myers Squibb noted in the press release.
Find the full Bristol-Myers Squibb press release on the FDA website.
Bristol-Myers Squibb is recalling one lot of Eliquis (apixaban) tablets, according to a company announcement on the Food and Drug Administration website.
The recall is based on a customer complaint that a bottle labeled as containing 5 mg tablets of Eliquis actually contained 2.5 mg tablets of Eliquis. The lot in question was distributed nationwide to wholesalers and retail pharmacies in February 2017. The recall is voluntary, the company noted.
“There are distinct visible differences between the two tablet strengths, including colors, size, and markings that distinguish the 2.5 mg and 5 mg tablets and decrease the likelihood of an incorrect dose,” Bristol-Myers Squibb noted in the press release.
Find the full Bristol-Myers Squibb press release on the FDA website.
Bristol-Myers Squibb is recalling one lot of Eliquis (apixaban) tablets, according to a company announcement on the Food and Drug Administration website.
The recall is based on a customer complaint that a bottle labeled as containing 5 mg tablets of Eliquis actually contained 2.5 mg tablets of Eliquis. The lot in question was distributed nationwide to wholesalers and retail pharmacies in February 2017. The recall is voluntary, the company noted.
“There are distinct visible differences between the two tablet strengths, including colors, size, and markings that distinguish the 2.5 mg and 5 mg tablets and decrease the likelihood of an incorrect dose,” Bristol-Myers Squibb noted in the press release.
Find the full Bristol-Myers Squibb press release on the FDA website.
FDA approves generic version of HIV drug Truvada
The U.S. Food and Drug Administration has approved the first generic version of emtricitabine and tenofovir disoproxil fumarate tablets, previously known by the brand name Truvada, for the treatment of HIV-1 infection.
Like Truvada, the generic version of the drug – produced by Teva Pharmaceuticals USA and approved in 200-mg/300-mg tablet form – is indicated for use in combination with other antiretrovirals for patients infected with HIV-1 and for pre-exposure prophylaxis (PrEP) to prevent sexually-acquired HIV infection in high-risk adults.
Women infected with HIV-1 should not breastfeed while taking emtricitabine and tenofovir disoproxil fumarate, the FDA said, and the drug can be used only in pediatric patients weighing more than 17 kg.
rpizzi@frontlinemedcom.com
On Twitter @richpizzi
The U.S. Food and Drug Administration has approved the first generic version of emtricitabine and tenofovir disoproxil fumarate tablets, previously known by the brand name Truvada, for the treatment of HIV-1 infection.
Like Truvada, the generic version of the drug – produced by Teva Pharmaceuticals USA and approved in 200-mg/300-mg tablet form – is indicated for use in combination with other antiretrovirals for patients infected with HIV-1 and for pre-exposure prophylaxis (PrEP) to prevent sexually-acquired HIV infection in high-risk adults.
Women infected with HIV-1 should not breastfeed while taking emtricitabine and tenofovir disoproxil fumarate, the FDA said, and the drug can be used only in pediatric patients weighing more than 17 kg.
rpizzi@frontlinemedcom.com
On Twitter @richpizzi
The U.S. Food and Drug Administration has approved the first generic version of emtricitabine and tenofovir disoproxil fumarate tablets, previously known by the brand name Truvada, for the treatment of HIV-1 infection.
Like Truvada, the generic version of the drug – produced by Teva Pharmaceuticals USA and approved in 200-mg/300-mg tablet form – is indicated for use in combination with other antiretrovirals for patients infected with HIV-1 and for pre-exposure prophylaxis (PrEP) to prevent sexually-acquired HIV infection in high-risk adults.
Women infected with HIV-1 should not breastfeed while taking emtricitabine and tenofovir disoproxil fumarate, the FDA said, and the drug can be used only in pediatric patients weighing more than 17 kg.
rpizzi@frontlinemedcom.com
On Twitter @richpizzi
New approval lights up gliomas to aid resection
The Food and Drug Administration has approved aminolevulinic acid hydrochloride (Gleolan) to help visualize gliomas during surgery and allow for more complete resection.
Aminolevulinic acid hydrochloride lights up the tumor so surgeons can distinguish it from healthy tissue. Patients take the drug orally – 20 mg/kg – approximately 3 hours before anesthesia. Glioma cells take it up and convert it to the fluorescent chemical protoporphyrin IX. When illuminated under blue light, protoporphyrin in the tumor glows an intense red, while normal brain tissue appears blue, enabling “the surgeon to see the tumor more clearly during brain surgery and to remove it more accurately, sparing healthy brain tissue,” according to information from NX Development Corp, which markets Gleolan.
In a phase III trial of 349 patients with suspected malignant glioma amenable to complete resection, a contrast-enhanced tumor was resected in 64% of patients in the aminolevulinic acid (ALA) arm, versus 38 % of patients in the control-group, who had conventional resection under white light (P less than .001); 20.5 % of ALA patients versus 11 % patients in the control arm were alive at 6 months without progression.
FDA officials noted that there’s a risk of false negatives and positives with ALA, and that “an increase in the extent of resection might increase the risk of serious neurologic deficits in the short term.”
Side effects in preapproval studies included fever, hypotension, nausea, and vomiting in more than 1% percent of patients within a week of surgery. Adverse events included chills, abnormal liver function tests, and diarrhea in less than 1% of patients within 6 weeks of surgery.
The Food and Drug Administration has approved aminolevulinic acid hydrochloride (Gleolan) to help visualize gliomas during surgery and allow for more complete resection.
Aminolevulinic acid hydrochloride lights up the tumor so surgeons can distinguish it from healthy tissue. Patients take the drug orally – 20 mg/kg – approximately 3 hours before anesthesia. Glioma cells take it up and convert it to the fluorescent chemical protoporphyrin IX. When illuminated under blue light, protoporphyrin in the tumor glows an intense red, while normal brain tissue appears blue, enabling “the surgeon to see the tumor more clearly during brain surgery and to remove it more accurately, sparing healthy brain tissue,” according to information from NX Development Corp, which markets Gleolan.
In a phase III trial of 349 patients with suspected malignant glioma amenable to complete resection, a contrast-enhanced tumor was resected in 64% of patients in the aminolevulinic acid (ALA) arm, versus 38 % of patients in the control-group, who had conventional resection under white light (P less than .001); 20.5 % of ALA patients versus 11 % patients in the control arm were alive at 6 months without progression.
FDA officials noted that there’s a risk of false negatives and positives with ALA, and that “an increase in the extent of resection might increase the risk of serious neurologic deficits in the short term.”
Side effects in preapproval studies included fever, hypotension, nausea, and vomiting in more than 1% percent of patients within a week of surgery. Adverse events included chills, abnormal liver function tests, and diarrhea in less than 1% of patients within 6 weeks of surgery.
The Food and Drug Administration has approved aminolevulinic acid hydrochloride (Gleolan) to help visualize gliomas during surgery and allow for more complete resection.
Aminolevulinic acid hydrochloride lights up the tumor so surgeons can distinguish it from healthy tissue. Patients take the drug orally – 20 mg/kg – approximately 3 hours before anesthesia. Glioma cells take it up and convert it to the fluorescent chemical protoporphyrin IX. When illuminated under blue light, protoporphyrin in the tumor glows an intense red, while normal brain tissue appears blue, enabling “the surgeon to see the tumor more clearly during brain surgery and to remove it more accurately, sparing healthy brain tissue,” according to information from NX Development Corp, which markets Gleolan.
In a phase III trial of 349 patients with suspected malignant glioma amenable to complete resection, a contrast-enhanced tumor was resected in 64% of patients in the aminolevulinic acid (ALA) arm, versus 38 % of patients in the control-group, who had conventional resection under white light (P less than .001); 20.5 % of ALA patients versus 11 % patients in the control arm were alive at 6 months without progression.
FDA officials noted that there’s a risk of false negatives and positives with ALA, and that “an increase in the extent of resection might increase the risk of serious neurologic deficits in the short term.”
Side effects in preapproval studies included fever, hypotension, nausea, and vomiting in more than 1% percent of patients within a week of surgery. Adverse events included chills, abnormal liver function tests, and diarrhea in less than 1% of patients within 6 weeks of surgery.
Extended-release Aristada OK’d for 2-month dosing for schizophrenia
The Food and Drug Administration has expanded labeling of extended-release aripiprazole lauroxil (Aristada) to allow for administration once every 2 months at a dose of 1,064 mg, for schizophrenia.
Depending on patient needs, treatment now can be initiated at a dose of 441 mg, 662 mg, or 882 mg administered monthly; 882 mg administered every 6 weeks; or 1,064 mg administered every 2 months. For patients who have never taken aripiprazole, “establish tolerability with oral aripiprazole prior to initiating treatment with Aristada. Due to the half-life of oral aripiprazole, it may take up to 2 weeks to fully assess tolerability,” according to the updated labeling. The new 2-month option is expected to be available in mid-June.
Another extended-release IM aripiprazole option, (Abilify Maintena, Otsuka) is approved only for once-a-month injection.
Approval of the bimonthly dose was based on pharmacokinetic data showing long-term therapeutic aripiprazole plasma levels. Labeling did not note whether the higher dose is associated with increased adverse events. Aristada originally was approved in 2015.
As with other atypical antipsychotics, Aristada labeling notes that the drug should not be used in elderly patients with dementia because of the increased risk of fatal strokes. The labeling also warns of the possibility of tardive dyskinesia, metabolic derangements, compulsive behaviors, agranulocytosis, and other risks.
The Food and Drug Administration has expanded labeling of extended-release aripiprazole lauroxil (Aristada) to allow for administration once every 2 months at a dose of 1,064 mg, for schizophrenia.
Depending on patient needs, treatment now can be initiated at a dose of 441 mg, 662 mg, or 882 mg administered monthly; 882 mg administered every 6 weeks; or 1,064 mg administered every 2 months. For patients who have never taken aripiprazole, “establish tolerability with oral aripiprazole prior to initiating treatment with Aristada. Due to the half-life of oral aripiprazole, it may take up to 2 weeks to fully assess tolerability,” according to the updated labeling. The new 2-month option is expected to be available in mid-June.
Another extended-release IM aripiprazole option, (Abilify Maintena, Otsuka) is approved only for once-a-month injection.
Approval of the bimonthly dose was based on pharmacokinetic data showing long-term therapeutic aripiprazole plasma levels. Labeling did not note whether the higher dose is associated with increased adverse events. Aristada originally was approved in 2015.
As with other atypical antipsychotics, Aristada labeling notes that the drug should not be used in elderly patients with dementia because of the increased risk of fatal strokes. The labeling also warns of the possibility of tardive dyskinesia, metabolic derangements, compulsive behaviors, agranulocytosis, and other risks.
The Food and Drug Administration has expanded labeling of extended-release aripiprazole lauroxil (Aristada) to allow for administration once every 2 months at a dose of 1,064 mg, for schizophrenia.
Depending on patient needs, treatment now can be initiated at a dose of 441 mg, 662 mg, or 882 mg administered monthly; 882 mg administered every 6 weeks; or 1,064 mg administered every 2 months. For patients who have never taken aripiprazole, “establish tolerability with oral aripiprazole prior to initiating treatment with Aristada. Due to the half-life of oral aripiprazole, it may take up to 2 weeks to fully assess tolerability,” according to the updated labeling. The new 2-month option is expected to be available in mid-June.
Another extended-release IM aripiprazole option, (Abilify Maintena, Otsuka) is approved only for once-a-month injection.
Approval of the bimonthly dose was based on pharmacokinetic data showing long-term therapeutic aripiprazole plasma levels. Labeling did not note whether the higher dose is associated with increased adverse events. Aristada originally was approved in 2015.
As with other atypical antipsychotics, Aristada labeling notes that the drug should not be used in elderly patients with dementia because of the increased risk of fatal strokes. The labeling also warns of the possibility of tardive dyskinesia, metabolic derangements, compulsive behaviors, agranulocytosis, and other risks.
CDC: First-trimester Zika infection had highest rate of birth defects
One in 12 infant or fetus born to mothers from the U.S. territories with laboratory-confirmed Zika infection during the first trimester had a birth defect possibly-associated with the infection, officials from the Centers for Disease Control and Prevention reported.
Overall, there were 3,930 pregnant women with laboratory evidence of possible Zika infection reported in the U.S. territories during Jan. 1, 2016-May 24, 2017. Of the 2,549 completed pregnancies, 122 resulted in a fetus or infant with possible Zika-related birth defects. The greatest number of birth defects was for maternal infections in the first trimester at 8%, followed by 5% in the second trimester, and 4% in the third trimester (MMWR. 2017, June 8. doi: 10.15585/mmwr.mm6623e1).
“These data indicate that Zika virus is associated with risks to pregnant women and their babies, even when the infection is identified later during pregnancy,” Dr. Schuchat said. “Although we are still learning about the full range of birth defects that can occur within a woman infected with Zika during pregnancy, we know that it causes brain abnormalities, vision problems, and other consequences of brain damage that might require long-term specialized care.”
In depth analysis of Zika side effects among the studied population found that 108 (89%) of the 122 fetuses or infants with infection confirmed by nucleic acid testing were diagnosed with brain abnormalities and/or microcephaly.
Researchers also found potential gaps in the evaluation of infants at birth with possible congenital Zika virus infections in the U.S. territories, according to Peggy Honein, PhD, a coleader of the CDC Pregnancy and Birth Defects Task Force.
“There are still opportunities to ensure every health care provider is aware of how to screen for exposure to Zika, the need for comprehensive evaluation of infants, and how to monitor and provide follow-up care,” Dr. Honein said. “Identification and follow-ups with laboratory evidence of Zika infection during pregnancy can facilitate timely and appropriate clinical intervention services and help assess their future needs.”
This research was limited by the size of the population analyzed, which was small and, therefore, may not be the full scope of the Zika population. The clinical guidance for infants was also changed in August of 2016, which may have affected reporting, officials said.
To help collect more accurate data, U.S. territories will begin using the same standard case definition as used by the U.S. states and Washington, DC starting June 22, 2017.
One of the investigators reported personal fees from Population Services International, Dexis Consulting Group, and Public Health Institute outside the submitted work. The other investigators reported no relevant financial disclosures.
ezimmerman@frontlinemedcom.com
On Twitter @eaztweets
One in 12 infant or fetus born to mothers from the U.S. territories with laboratory-confirmed Zika infection during the first trimester had a birth defect possibly-associated with the infection, officials from the Centers for Disease Control and Prevention reported.
Overall, there were 3,930 pregnant women with laboratory evidence of possible Zika infection reported in the U.S. territories during Jan. 1, 2016-May 24, 2017. Of the 2,549 completed pregnancies, 122 resulted in a fetus or infant with possible Zika-related birth defects. The greatest number of birth defects was for maternal infections in the first trimester at 8%, followed by 5% in the second trimester, and 4% in the third trimester (MMWR. 2017, June 8. doi: 10.15585/mmwr.mm6623e1).
“These data indicate that Zika virus is associated with risks to pregnant women and their babies, even when the infection is identified later during pregnancy,” Dr. Schuchat said. “Although we are still learning about the full range of birth defects that can occur within a woman infected with Zika during pregnancy, we know that it causes brain abnormalities, vision problems, and other consequences of brain damage that might require long-term specialized care.”
In depth analysis of Zika side effects among the studied population found that 108 (89%) of the 122 fetuses or infants with infection confirmed by nucleic acid testing were diagnosed with brain abnormalities and/or microcephaly.
Researchers also found potential gaps in the evaluation of infants at birth with possible congenital Zika virus infections in the U.S. territories, according to Peggy Honein, PhD, a coleader of the CDC Pregnancy and Birth Defects Task Force.
“There are still opportunities to ensure every health care provider is aware of how to screen for exposure to Zika, the need for comprehensive evaluation of infants, and how to monitor and provide follow-up care,” Dr. Honein said. “Identification and follow-ups with laboratory evidence of Zika infection during pregnancy can facilitate timely and appropriate clinical intervention services and help assess their future needs.”
This research was limited by the size of the population analyzed, which was small and, therefore, may not be the full scope of the Zika population. The clinical guidance for infants was also changed in August of 2016, which may have affected reporting, officials said.
To help collect more accurate data, U.S. territories will begin using the same standard case definition as used by the U.S. states and Washington, DC starting June 22, 2017.
One of the investigators reported personal fees from Population Services International, Dexis Consulting Group, and Public Health Institute outside the submitted work. The other investigators reported no relevant financial disclosures.
ezimmerman@frontlinemedcom.com
On Twitter @eaztweets
One in 12 infant or fetus born to mothers from the U.S. territories with laboratory-confirmed Zika infection during the first trimester had a birth defect possibly-associated with the infection, officials from the Centers for Disease Control and Prevention reported.
Overall, there were 3,930 pregnant women with laboratory evidence of possible Zika infection reported in the U.S. territories during Jan. 1, 2016-May 24, 2017. Of the 2,549 completed pregnancies, 122 resulted in a fetus or infant with possible Zika-related birth defects. The greatest number of birth defects was for maternal infections in the first trimester at 8%, followed by 5% in the second trimester, and 4% in the third trimester (MMWR. 2017, June 8. doi: 10.15585/mmwr.mm6623e1).
“These data indicate that Zika virus is associated with risks to pregnant women and their babies, even when the infection is identified later during pregnancy,” Dr. Schuchat said. “Although we are still learning about the full range of birth defects that can occur within a woman infected with Zika during pregnancy, we know that it causes brain abnormalities, vision problems, and other consequences of brain damage that might require long-term specialized care.”
In depth analysis of Zika side effects among the studied population found that 108 (89%) of the 122 fetuses or infants with infection confirmed by nucleic acid testing were diagnosed with brain abnormalities and/or microcephaly.
Researchers also found potential gaps in the evaluation of infants at birth with possible congenital Zika virus infections in the U.S. territories, according to Peggy Honein, PhD, a coleader of the CDC Pregnancy and Birth Defects Task Force.
“There are still opportunities to ensure every health care provider is aware of how to screen for exposure to Zika, the need for comprehensive evaluation of infants, and how to monitor and provide follow-up care,” Dr. Honein said. “Identification and follow-ups with laboratory evidence of Zika infection during pregnancy can facilitate timely and appropriate clinical intervention services and help assess their future needs.”
This research was limited by the size of the population analyzed, which was small and, therefore, may not be the full scope of the Zika population. The clinical guidance for infants was also changed in August of 2016, which may have affected reporting, officials said.
To help collect more accurate data, U.S. territories will begin using the same standard case definition as used by the U.S. states and Washington, DC starting June 22, 2017.
One of the investigators reported personal fees from Population Services International, Dexis Consulting Group, and Public Health Institute outside the submitted work. The other investigators reported no relevant financial disclosures.
ezimmerman@frontlinemedcom.com
On Twitter @eaztweets
FROM MMWR
FDA approves Sapien 3 transcatheter valve for bioprosthetic valve failure
The Food and Drug Administration announced June 5 the approval of an expanded indication for the Sapien 3 Transcatheter Heart Valve (THV) for patients with symptomatic heart disease caused by failure of a previously placed bioprosthetic aortic or mitral valve who have a risk of death or severe complications from repeat surgery.
This is the first FDA approval for the expanded use of the Sapien 3 THV as a valve-in-valve treatment. Such procedures provide an alternative to repeat surgery.
“For the first time, a regulatory agency is approving a transcatheter heart valve as a valve-in-valve treatment when bioprosthetic mitral or aortic valves fail in patients who are at high or greater risk of complications from repeat surgery,” Bram Zuckerman, MD, director of the division of cardiovascular devices at the FDA’s Center for Devices and Radiological Health, said in a press release. “This new approval offers U.S. patients with failing surgical bioprosthetic aortic or mitral valves a less-invasive treatment option.”
Originally, the FDA approved the Sapien 3 THV for transcatheter aortic valve replacement (TAVR) as an alternative to surgical aortic valve replacement for patients with native aortic stenosis whose risk for death or severe complications from surgery is high or greater. Then in 2016, the FDA expanded the TAVR indication for Sapien 3 THV to include patients who are at intermediate surgical risk for death or complications.
Read the full press release on the FDA’s website.
The Food and Drug Administration announced June 5 the approval of an expanded indication for the Sapien 3 Transcatheter Heart Valve (THV) for patients with symptomatic heart disease caused by failure of a previously placed bioprosthetic aortic or mitral valve who have a risk of death or severe complications from repeat surgery.
This is the first FDA approval for the expanded use of the Sapien 3 THV as a valve-in-valve treatment. Such procedures provide an alternative to repeat surgery.
“For the first time, a regulatory agency is approving a transcatheter heart valve as a valve-in-valve treatment when bioprosthetic mitral or aortic valves fail in patients who are at high or greater risk of complications from repeat surgery,” Bram Zuckerman, MD, director of the division of cardiovascular devices at the FDA’s Center for Devices and Radiological Health, said in a press release. “This new approval offers U.S. patients with failing surgical bioprosthetic aortic or mitral valves a less-invasive treatment option.”
Originally, the FDA approved the Sapien 3 THV for transcatheter aortic valve replacement (TAVR) as an alternative to surgical aortic valve replacement for patients with native aortic stenosis whose risk for death or severe complications from surgery is high or greater. Then in 2016, the FDA expanded the TAVR indication for Sapien 3 THV to include patients who are at intermediate surgical risk for death or complications.
Read the full press release on the FDA’s website.
The Food and Drug Administration announced June 5 the approval of an expanded indication for the Sapien 3 Transcatheter Heart Valve (THV) for patients with symptomatic heart disease caused by failure of a previously placed bioprosthetic aortic or mitral valve who have a risk of death or severe complications from repeat surgery.
This is the first FDA approval for the expanded use of the Sapien 3 THV as a valve-in-valve treatment. Such procedures provide an alternative to repeat surgery.
“For the first time, a regulatory agency is approving a transcatheter heart valve as a valve-in-valve treatment when bioprosthetic mitral or aortic valves fail in patients who are at high or greater risk of complications from repeat surgery,” Bram Zuckerman, MD, director of the division of cardiovascular devices at the FDA’s Center for Devices and Radiological Health, said in a press release. “This new approval offers U.S. patients with failing surgical bioprosthetic aortic or mitral valves a less-invasive treatment option.”
Originally, the FDA approved the Sapien 3 THV for transcatheter aortic valve replacement (TAVR) as an alternative to surgical aortic valve replacement for patients with native aortic stenosis whose risk for death or severe complications from surgery is high or greater. Then in 2016, the FDA expanded the TAVR indication for Sapien 3 THV to include patients who are at intermediate surgical risk for death or complications.
Read the full press release on the FDA’s website.