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FDA approves first treatment for metastatic Merkel cell carcinoma
The Food and Drug Administration has granted accelerated approval to avelumab for the treatment of metastatic Merkel cell carcinoma (MCC) in adult and pediatric patients aged 12 years and older.
Avelumab, a programmed death-ligand 1 (PD-L1)–blocking human IgG1 lambda monoclonal antibody, is the first FDA-approved treatment for metastatic MCC.
Approval was based on a 33% overall response rate in a single arm trial (JAVELIN Merkel 200 trial) of 88 patients with metastatic MCC who had been previously treated with at least one prior chemotherapy regimen, the FDA said in a written statement.
The response duration among that 33% ranged from 2.8 to 23.3+ months, and 86% of responses were durable for 6 months or more. “Responses were observed in patients regardless of PD-L1 tumor expression or presence of Merkel cell polyomavirus,” the FDA said.
There were safety data in 1,738 patients, who received 10 mg/kg of avelumab every 2 weeks. Immune-mediated adverse reactions (pneumonitis, colitis, hepatitis, adrenal insufficiency, hypo- and hyperthyroidism, diabetes mellitus, and nephritis) and life-threatening infusion reactions were the most common, serious adverse events associated with avelumab. Of the 88 patients in the JAVELIN Merkel 200 trial, the most common adverse reactions were fatigue, musculoskeletal pain, diarrhea, nausea, infusion-related reaction, rash, decreased appetite, and peripheral edema. Serious adverse reactions that occurred in more than one patient in the trial were acute kidney injury, anemia, abdominal pain, ileus, asthenia, and cellulitis, the FDA said.
The recommended dose of avelumab is 10 mg/kg administered in an intravenous infusion over 60 minutes every 2 weeks. Labeling includes the recommendation that all patients should be premedicated with an antihistamine and acetaminophen before each of the first four infusions.
“As a condition of accelerated approval, an additional study is required to confirm the clinical benefit of avelumab for this indication,” according to the FDA.
The drug is being marketed as Bavencio by EMD Serono.
The Food and Drug Administration has granted accelerated approval to avelumab for the treatment of metastatic Merkel cell carcinoma (MCC) in adult and pediatric patients aged 12 years and older.
Avelumab, a programmed death-ligand 1 (PD-L1)–blocking human IgG1 lambda monoclonal antibody, is the first FDA-approved treatment for metastatic MCC.
Approval was based on a 33% overall response rate in a single arm trial (JAVELIN Merkel 200 trial) of 88 patients with metastatic MCC who had been previously treated with at least one prior chemotherapy regimen, the FDA said in a written statement.
The response duration among that 33% ranged from 2.8 to 23.3+ months, and 86% of responses were durable for 6 months or more. “Responses were observed in patients regardless of PD-L1 tumor expression or presence of Merkel cell polyomavirus,” the FDA said.
There were safety data in 1,738 patients, who received 10 mg/kg of avelumab every 2 weeks. Immune-mediated adverse reactions (pneumonitis, colitis, hepatitis, adrenal insufficiency, hypo- and hyperthyroidism, diabetes mellitus, and nephritis) and life-threatening infusion reactions were the most common, serious adverse events associated with avelumab. Of the 88 patients in the JAVELIN Merkel 200 trial, the most common adverse reactions were fatigue, musculoskeletal pain, diarrhea, nausea, infusion-related reaction, rash, decreased appetite, and peripheral edema. Serious adverse reactions that occurred in more than one patient in the trial were acute kidney injury, anemia, abdominal pain, ileus, asthenia, and cellulitis, the FDA said.
The recommended dose of avelumab is 10 mg/kg administered in an intravenous infusion over 60 minutes every 2 weeks. Labeling includes the recommendation that all patients should be premedicated with an antihistamine and acetaminophen before each of the first four infusions.
“As a condition of accelerated approval, an additional study is required to confirm the clinical benefit of avelumab for this indication,” according to the FDA.
The drug is being marketed as Bavencio by EMD Serono.
The Food and Drug Administration has granted accelerated approval to avelumab for the treatment of metastatic Merkel cell carcinoma (MCC) in adult and pediatric patients aged 12 years and older.
Avelumab, a programmed death-ligand 1 (PD-L1)–blocking human IgG1 lambda monoclonal antibody, is the first FDA-approved treatment for metastatic MCC.
Approval was based on a 33% overall response rate in a single arm trial (JAVELIN Merkel 200 trial) of 88 patients with metastatic MCC who had been previously treated with at least one prior chemotherapy regimen, the FDA said in a written statement.
The response duration among that 33% ranged from 2.8 to 23.3+ months, and 86% of responses were durable for 6 months or more. “Responses were observed in patients regardless of PD-L1 tumor expression or presence of Merkel cell polyomavirus,” the FDA said.
There were safety data in 1,738 patients, who received 10 mg/kg of avelumab every 2 weeks. Immune-mediated adverse reactions (pneumonitis, colitis, hepatitis, adrenal insufficiency, hypo- and hyperthyroidism, diabetes mellitus, and nephritis) and life-threatening infusion reactions were the most common, serious adverse events associated with avelumab. Of the 88 patients in the JAVELIN Merkel 200 trial, the most common adverse reactions were fatigue, musculoskeletal pain, diarrhea, nausea, infusion-related reaction, rash, decreased appetite, and peripheral edema. Serious adverse reactions that occurred in more than one patient in the trial were acute kidney injury, anemia, abdominal pain, ileus, asthenia, and cellulitis, the FDA said.
The recommended dose of avelumab is 10 mg/kg administered in an intravenous infusion over 60 minutes every 2 weeks. Labeling includes the recommendation that all patients should be premedicated with an antihistamine and acetaminophen before each of the first four infusions.
“As a condition of accelerated approval, an additional study is required to confirm the clinical benefit of avelumab for this indication,” according to the FDA.
The drug is being marketed as Bavencio by EMD Serono.
FDA approves safinamide to treat Parkinson’s disease
The U.S. Food and Drug Administration approved safinamide tablets on March 21 as an add-on treatment for patients with Parkinson’s disease who are currently taking levodopa/carbidopa and experiencing “off” episodes.
Newron Pharmaceuticals will market safinamide under the brand name Xadago.
The most common adverse reactions observed in patients taking safinamide were uncontrolled involuntary movement, falls, nausea, and insomnia.
In its announcement of the approval, the FDA noted that patients should not take safinamide if they have severe liver problems, take dextromethorphan, or take a monoamine oxidase inhibitor, because the two together may cause a sudden severe increase in blood pressure. Safinamide also should not be taken by patients who use a opioid drug, St. John’s wort, certain antidepressants (such as serotonin-norepinephrine reuptake inhibitors, tricyclics, tetracyclics, and triazolopyridines), or cyclobenzaprine, because it may cause a life-threatening reaction called serotonin syndrome.
The U.S. Food and Drug Administration approved safinamide tablets on March 21 as an add-on treatment for patients with Parkinson’s disease who are currently taking levodopa/carbidopa and experiencing “off” episodes.
Newron Pharmaceuticals will market safinamide under the brand name Xadago.
The most common adverse reactions observed in patients taking safinamide were uncontrolled involuntary movement, falls, nausea, and insomnia.
In its announcement of the approval, the FDA noted that patients should not take safinamide if they have severe liver problems, take dextromethorphan, or take a monoamine oxidase inhibitor, because the two together may cause a sudden severe increase in blood pressure. Safinamide also should not be taken by patients who use a opioid drug, St. John’s wort, certain antidepressants (such as serotonin-norepinephrine reuptake inhibitors, tricyclics, tetracyclics, and triazolopyridines), or cyclobenzaprine, because it may cause a life-threatening reaction called serotonin syndrome.
The U.S. Food and Drug Administration approved safinamide tablets on March 21 as an add-on treatment for patients with Parkinson’s disease who are currently taking levodopa/carbidopa and experiencing “off” episodes.
Newron Pharmaceuticals will market safinamide under the brand name Xadago.
The most common adverse reactions observed in patients taking safinamide were uncontrolled involuntary movement, falls, nausea, and insomnia.
In its announcement of the approval, the FDA noted that patients should not take safinamide if they have severe liver problems, take dextromethorphan, or take a monoamine oxidase inhibitor, because the two together may cause a sudden severe increase in blood pressure. Safinamide also should not be taken by patients who use a opioid drug, St. John’s wort, certain antidepressants (such as serotonin-norepinephrine reuptake inhibitors, tricyclics, tetracyclics, and triazolopyridines), or cyclobenzaprine, because it may cause a life-threatening reaction called serotonin syndrome.
STD testing in youth hindered by confidentiality concerns
Adolescents and young adults on their parents’ health insurance plan are less likely to receive sexual preventive health care, such as sexual risk assessments and testing for sexually transmitted disease, a study found.
Further, teen girls (aged 15-17 years), were more than twice as likely to be tested for chlamydia if they met with their provider alone than if they did not, researchers found.
“Confidentiality issues, including concerns that parents might find out, might be barriers to the use of STD [sexually transmitted disease] services among some subpopulations,” Jami S. Leichliter, PhD, and colleagues at the Centers for Disease Control and Prevention wrote. “Public health efforts to reduce these confidentiality concerns might be useful,” such as providers meeting privately for at least part of an appointment with an adolescent (MMWR. 2017 Mar 10;66[9]:237-41).
The researchers examined data collected from the 2013-2015 National Survey of Family Growth regarding sexual and reproductive health care experiences and behaviors of youth with sexual experience, specifically teens aged 15-17 and young adults aged 18-25 who were on their parents’ health plan. Sexual experience refers to having ever had vaginal, anal, or oral sex with any partner.
Overall, 12.7% of these youth avoided seeking care for sexual and reproductive health because they worried their parents could find out. For those aged 15-17 years, the rate was even higher, at 22.6%.
These concerns were also reflected in the overall prevalence of chlamydia screenings: Just 17.1% of young women who worried about confidentiality had been screened for chlamydia, compared with 38.7% of young women who did not report that concern.
The researchers also compared teens aged 15-17 who had and had not received a sexual risk assessment, which includes being asked by a provider about their (or their partners’) sexual orientation, number of sexual partners, condom use, and types of sex. Among teens who met with a provider alone in the past year, 71.1% reported receiving a sexual risk assessment, compared with about 36.6% who did not meet privately with a provider.
Similarly, 34.0% of teen girls (aged 15-17 years) who saw their provider alone were tested for chlamydia, compared with 14.9% who never met with their provider alone. Slightly more teen boys (13.6%) received STD testing if they met with their provider alone than if they didn’t (9.5%), but this difference did not reach statistical significance.
The study was funded by the Centers for Disease Control and Prevention. The authors did not report any disclosures.
Adolescents and young adults on their parents’ health insurance plan are less likely to receive sexual preventive health care, such as sexual risk assessments and testing for sexually transmitted disease, a study found.
Further, teen girls (aged 15-17 years), were more than twice as likely to be tested for chlamydia if they met with their provider alone than if they did not, researchers found.
“Confidentiality issues, including concerns that parents might find out, might be barriers to the use of STD [sexually transmitted disease] services among some subpopulations,” Jami S. Leichliter, PhD, and colleagues at the Centers for Disease Control and Prevention wrote. “Public health efforts to reduce these confidentiality concerns might be useful,” such as providers meeting privately for at least part of an appointment with an adolescent (MMWR. 2017 Mar 10;66[9]:237-41).
The researchers examined data collected from the 2013-2015 National Survey of Family Growth regarding sexual and reproductive health care experiences and behaviors of youth with sexual experience, specifically teens aged 15-17 and young adults aged 18-25 who were on their parents’ health plan. Sexual experience refers to having ever had vaginal, anal, or oral sex with any partner.
Overall, 12.7% of these youth avoided seeking care for sexual and reproductive health because they worried their parents could find out. For those aged 15-17 years, the rate was even higher, at 22.6%.
These concerns were also reflected in the overall prevalence of chlamydia screenings: Just 17.1% of young women who worried about confidentiality had been screened for chlamydia, compared with 38.7% of young women who did not report that concern.
The researchers also compared teens aged 15-17 who had and had not received a sexual risk assessment, which includes being asked by a provider about their (or their partners’) sexual orientation, number of sexual partners, condom use, and types of sex. Among teens who met with a provider alone in the past year, 71.1% reported receiving a sexual risk assessment, compared with about 36.6% who did not meet privately with a provider.
Similarly, 34.0% of teen girls (aged 15-17 years) who saw their provider alone were tested for chlamydia, compared with 14.9% who never met with their provider alone. Slightly more teen boys (13.6%) received STD testing if they met with their provider alone than if they didn’t (9.5%), but this difference did not reach statistical significance.
The study was funded by the Centers for Disease Control and Prevention. The authors did not report any disclosures.
Adolescents and young adults on their parents’ health insurance plan are less likely to receive sexual preventive health care, such as sexual risk assessments and testing for sexually transmitted disease, a study found.
Further, teen girls (aged 15-17 years), were more than twice as likely to be tested for chlamydia if they met with their provider alone than if they did not, researchers found.
“Confidentiality issues, including concerns that parents might find out, might be barriers to the use of STD [sexually transmitted disease] services among some subpopulations,” Jami S. Leichliter, PhD, and colleagues at the Centers for Disease Control and Prevention wrote. “Public health efforts to reduce these confidentiality concerns might be useful,” such as providers meeting privately for at least part of an appointment with an adolescent (MMWR. 2017 Mar 10;66[9]:237-41).
The researchers examined data collected from the 2013-2015 National Survey of Family Growth regarding sexual and reproductive health care experiences and behaviors of youth with sexual experience, specifically teens aged 15-17 and young adults aged 18-25 who were on their parents’ health plan. Sexual experience refers to having ever had vaginal, anal, or oral sex with any partner.
Overall, 12.7% of these youth avoided seeking care for sexual and reproductive health because they worried their parents could find out. For those aged 15-17 years, the rate was even higher, at 22.6%.
These concerns were also reflected in the overall prevalence of chlamydia screenings: Just 17.1% of young women who worried about confidentiality had been screened for chlamydia, compared with 38.7% of young women who did not report that concern.
The researchers also compared teens aged 15-17 who had and had not received a sexual risk assessment, which includes being asked by a provider about their (or their partners’) sexual orientation, number of sexual partners, condom use, and types of sex. Among teens who met with a provider alone in the past year, 71.1% reported receiving a sexual risk assessment, compared with about 36.6% who did not meet privately with a provider.
Similarly, 34.0% of teen girls (aged 15-17 years) who saw their provider alone were tested for chlamydia, compared with 14.9% who never met with their provider alone. Slightly more teen boys (13.6%) received STD testing if they met with their provider alone than if they didn’t (9.5%), but this difference did not reach statistical significance.
The study was funded by the Centers for Disease Control and Prevention. The authors did not report any disclosures.
FROM MMWR
Key clinical point:
Major finding: Overall, 12.7% of sexually experienced youths (aged 15-25 years) who were on their parents’ health plan would not seek sexual and reproductive health care because of confidentiality concerns.
Data source: Responses from sexually experienced youth aged 15-25 years provided during the 2013-2015 U.S. National Survey of Family Growth.
Disclosures: The study was funded by the Centers for Disease Control and Prevention. The authors did not report any disclosures.
FDA approves ribociclib for HR+, HER2– advanced breast cancer
The Food and Drug Administration has approved ribociclib, a cyclin-dependent kinase (CDK) 4/6 inhibitor, in combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer.
Overall survival data is immature but approval was based on improvement in progression-free survival (PFS) among 334 women randomized to receive ribociclib plus letrozole compared to 334 women randomized to receive placebo plus letrozole in phase III MONALEESA-2 (hazard ratio, 0.556; 95% CI: 0.429, 0.720; P less than .0001).
Ribociclib 600 mg or placebo was administered orally once daily for 21 consecutive days, followed by 7 days off, with letrozole 2.5 mg administered orally once daily for 28 days. All patients were postmenopausal women with HR-positive, HER2-negative advanced or metastatic breast cancer who received no prior therapy for advanced disease. Treatment continued until disease progression or unacceptable toxicity,
The most common adverse reactions in patients taking ribociclib were neutropenia, nausea, fatigue, diarrhea, leukopenia, alopecia, vomiting, constipation, headache, and back pain. The most common grade 3 or 4 adverse reactions were neutropenia, leukopenia, abnormal liver function tests, lymphopenia, and vomiting. Ribociclib has been shown to prolong the QT interval in a concentration-dependent manner, the FDA warns.
Ribociclib is the second CDK4/6 inhibitor to receive approval for advanced breast cancer, following the accelerated approval of palbociclib (Ibrance) plus letrozole (Femara) as a first-line treatment for postmenopausal women with ER-postive, HER2-negative metastatic breast cancer in 2015. The FDA expanded the indication for fulvestrant to include use in combination with palbociclib in 2016.
Phase II trial data indicating activity of a third CDK 4/6 inhibitor, abemaciclib, in this patient population was presented at the 2016 ASCO Annual Meeting.
The recommended starting dose of ribociclib is 600 mg orally (three 200-mg tablets) taken once daily with or without food for 21 consecutive days followed by 7 days off treatment.
Full prescribing information for ribociclib is available here.
Ribociclib is being marketed as Kisqali by Novartis Pharmaceuticals Corp.
The Food and Drug Administration has approved ribociclib, a cyclin-dependent kinase (CDK) 4/6 inhibitor, in combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer.
Overall survival data is immature but approval was based on improvement in progression-free survival (PFS) among 334 women randomized to receive ribociclib plus letrozole compared to 334 women randomized to receive placebo plus letrozole in phase III MONALEESA-2 (hazard ratio, 0.556; 95% CI: 0.429, 0.720; P less than .0001).
Ribociclib 600 mg or placebo was administered orally once daily for 21 consecutive days, followed by 7 days off, with letrozole 2.5 mg administered orally once daily for 28 days. All patients were postmenopausal women with HR-positive, HER2-negative advanced or metastatic breast cancer who received no prior therapy for advanced disease. Treatment continued until disease progression or unacceptable toxicity,
The most common adverse reactions in patients taking ribociclib were neutropenia, nausea, fatigue, diarrhea, leukopenia, alopecia, vomiting, constipation, headache, and back pain. The most common grade 3 or 4 adverse reactions were neutropenia, leukopenia, abnormal liver function tests, lymphopenia, and vomiting. Ribociclib has been shown to prolong the QT interval in a concentration-dependent manner, the FDA warns.
Ribociclib is the second CDK4/6 inhibitor to receive approval for advanced breast cancer, following the accelerated approval of palbociclib (Ibrance) plus letrozole (Femara) as a first-line treatment for postmenopausal women with ER-postive, HER2-negative metastatic breast cancer in 2015. The FDA expanded the indication for fulvestrant to include use in combination with palbociclib in 2016.
Phase II trial data indicating activity of a third CDK 4/6 inhibitor, abemaciclib, in this patient population was presented at the 2016 ASCO Annual Meeting.
The recommended starting dose of ribociclib is 600 mg orally (three 200-mg tablets) taken once daily with or without food for 21 consecutive days followed by 7 days off treatment.
Full prescribing information for ribociclib is available here.
Ribociclib is being marketed as Kisqali by Novartis Pharmaceuticals Corp.
The Food and Drug Administration has approved ribociclib, a cyclin-dependent kinase (CDK) 4/6 inhibitor, in combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer.
Overall survival data is immature but approval was based on improvement in progression-free survival (PFS) among 334 women randomized to receive ribociclib plus letrozole compared to 334 women randomized to receive placebo plus letrozole in phase III MONALEESA-2 (hazard ratio, 0.556; 95% CI: 0.429, 0.720; P less than .0001).
Ribociclib 600 mg or placebo was administered orally once daily for 21 consecutive days, followed by 7 days off, with letrozole 2.5 mg administered orally once daily for 28 days. All patients were postmenopausal women with HR-positive, HER2-negative advanced or metastatic breast cancer who received no prior therapy for advanced disease. Treatment continued until disease progression or unacceptable toxicity,
The most common adverse reactions in patients taking ribociclib were neutropenia, nausea, fatigue, diarrhea, leukopenia, alopecia, vomiting, constipation, headache, and back pain. The most common grade 3 or 4 adverse reactions were neutropenia, leukopenia, abnormal liver function tests, lymphopenia, and vomiting. Ribociclib has been shown to prolong the QT interval in a concentration-dependent manner, the FDA warns.
Ribociclib is the second CDK4/6 inhibitor to receive approval for advanced breast cancer, following the accelerated approval of palbociclib (Ibrance) plus letrozole (Femara) as a first-line treatment for postmenopausal women with ER-postive, HER2-negative metastatic breast cancer in 2015. The FDA expanded the indication for fulvestrant to include use in combination with palbociclib in 2016.
Phase II trial data indicating activity of a third CDK 4/6 inhibitor, abemaciclib, in this patient population was presented at the 2016 ASCO Annual Meeting.
The recommended starting dose of ribociclib is 600 mg orally (three 200-mg tablets) taken once daily with or without food for 21 consecutive days followed by 7 days off treatment.
Full prescribing information for ribociclib is available here.
Ribociclib is being marketed as Kisqali by Novartis Pharmaceuticals Corp.
FDA committee approves strains for 2017-2018 flu shot
ROCKVILLE, MD. – A committee of Food and Drug Administration advisers backed the World Health Organization’s influenza vaccine recommendations for the 2017-2018 season at a meeting March 9.
In a unanimous vote, members of the Vaccines and Related Biological Products Advisory Committee recommended that trivalent vaccines for the 2017-2018 season should contain the following vaccine strains: A/Michigan/45/2015(H1N1)pdm09-like, A/Hong Kong/4801/2014(H3N2)-like, and B/Brisbane/60/2008-like.
These recommendations echo those from the 2016-2017 season, with the exception of a slight update to the H1N1 strain, which had previously been A/California/7/2009(H1N1)pdm09-like virus.
Regarding vaccine efficacy, the cell propagated A/Hong Kong strain was the strongest candidate, covering 93% of A(H3N2) viruses seen in the 2016-2017 season, according to Jacqueline Katz, PhD, director of the WHO Collaborating Center for Surveillance, Epidemiology and Control of Influenza at the Centers for Disease Control and Prevention. In comparison, the egg propagated version of the A/Hong Kong virus covered 59%.
For the influenza B virus, the Yamagata lineage and Victoria lineage strain cycled monthly as the predominant strain in the 2016-2017 season, with a split of “around 50/50,” leaning toward Yamagata in North America, Europe, and Oceana, Dr. Katz explained. The Victoria lineage, in some cases, accounted for nearly 75% of B viruses in Africa and South America.
Committee members expressed concern over the difference between strain prevalence in the United States and abroad and considered recommending a strain that did not coincide with the WHO recommendation, something that has not happened in the history of the advisory committee.
“I’m very aware of influenza vaccinations being a global enterprise, and companies manufacture vaccines for use in multiple countries,” said Committee Chair Kathryn Edwards, MD, professor of pediatrics at Vanderbilt University, Nashville, Tenn. “If we to select a B strain that differed from the WHO recommendation, would that adversely impact vaccine production for the U.S. market?”
Despite these questions, the committee continued to back the WHO recommendations.
Historically, the advisory committee has recommended flu vaccine strains earlier in the year, according to Beverly Taylor, PhD, head of influenza scientific affairs and pandemic readiness at Seqirus Vaccines. Dr. Taylor presented the vaccine manufacturers’ perspective. The delay has put added pressure on manufacturers.
“We haven’t seen impacts yet on start of vaccination dates,” said Dr. Taylor. “But the very clear message from manufacturers is if you keep squashing that manufacturing window, then there will reach a point where we are concerned we will see an impact on vaccine supply time.”
None of the committee members presented waivers of conflict of interest. While the FDA is not obligated to follow the recommendations of the advisory committee, it generally does.
ezimmerman@frontlinemedcom.com
On Twitter @EAZTweets
ROCKVILLE, MD. – A committee of Food and Drug Administration advisers backed the World Health Organization’s influenza vaccine recommendations for the 2017-2018 season at a meeting March 9.
In a unanimous vote, members of the Vaccines and Related Biological Products Advisory Committee recommended that trivalent vaccines for the 2017-2018 season should contain the following vaccine strains: A/Michigan/45/2015(H1N1)pdm09-like, A/Hong Kong/4801/2014(H3N2)-like, and B/Brisbane/60/2008-like.
These recommendations echo those from the 2016-2017 season, with the exception of a slight update to the H1N1 strain, which had previously been A/California/7/2009(H1N1)pdm09-like virus.
Regarding vaccine efficacy, the cell propagated A/Hong Kong strain was the strongest candidate, covering 93% of A(H3N2) viruses seen in the 2016-2017 season, according to Jacqueline Katz, PhD, director of the WHO Collaborating Center for Surveillance, Epidemiology and Control of Influenza at the Centers for Disease Control and Prevention. In comparison, the egg propagated version of the A/Hong Kong virus covered 59%.
For the influenza B virus, the Yamagata lineage and Victoria lineage strain cycled monthly as the predominant strain in the 2016-2017 season, with a split of “around 50/50,” leaning toward Yamagata in North America, Europe, and Oceana, Dr. Katz explained. The Victoria lineage, in some cases, accounted for nearly 75% of B viruses in Africa and South America.
Committee members expressed concern over the difference between strain prevalence in the United States and abroad and considered recommending a strain that did not coincide with the WHO recommendation, something that has not happened in the history of the advisory committee.
“I’m very aware of influenza vaccinations being a global enterprise, and companies manufacture vaccines for use in multiple countries,” said Committee Chair Kathryn Edwards, MD, professor of pediatrics at Vanderbilt University, Nashville, Tenn. “If we to select a B strain that differed from the WHO recommendation, would that adversely impact vaccine production for the U.S. market?”
Despite these questions, the committee continued to back the WHO recommendations.
Historically, the advisory committee has recommended flu vaccine strains earlier in the year, according to Beverly Taylor, PhD, head of influenza scientific affairs and pandemic readiness at Seqirus Vaccines. Dr. Taylor presented the vaccine manufacturers’ perspective. The delay has put added pressure on manufacturers.
“We haven’t seen impacts yet on start of vaccination dates,” said Dr. Taylor. “But the very clear message from manufacturers is if you keep squashing that manufacturing window, then there will reach a point where we are concerned we will see an impact on vaccine supply time.”
None of the committee members presented waivers of conflict of interest. While the FDA is not obligated to follow the recommendations of the advisory committee, it generally does.
ezimmerman@frontlinemedcom.com
On Twitter @EAZTweets
ROCKVILLE, MD. – A committee of Food and Drug Administration advisers backed the World Health Organization’s influenza vaccine recommendations for the 2017-2018 season at a meeting March 9.
In a unanimous vote, members of the Vaccines and Related Biological Products Advisory Committee recommended that trivalent vaccines for the 2017-2018 season should contain the following vaccine strains: A/Michigan/45/2015(H1N1)pdm09-like, A/Hong Kong/4801/2014(H3N2)-like, and B/Brisbane/60/2008-like.
These recommendations echo those from the 2016-2017 season, with the exception of a slight update to the H1N1 strain, which had previously been A/California/7/2009(H1N1)pdm09-like virus.
Regarding vaccine efficacy, the cell propagated A/Hong Kong strain was the strongest candidate, covering 93% of A(H3N2) viruses seen in the 2016-2017 season, according to Jacqueline Katz, PhD, director of the WHO Collaborating Center for Surveillance, Epidemiology and Control of Influenza at the Centers for Disease Control and Prevention. In comparison, the egg propagated version of the A/Hong Kong virus covered 59%.
For the influenza B virus, the Yamagata lineage and Victoria lineage strain cycled monthly as the predominant strain in the 2016-2017 season, with a split of “around 50/50,” leaning toward Yamagata in North America, Europe, and Oceana, Dr. Katz explained. The Victoria lineage, in some cases, accounted for nearly 75% of B viruses in Africa and South America.
Committee members expressed concern over the difference between strain prevalence in the United States and abroad and considered recommending a strain that did not coincide with the WHO recommendation, something that has not happened in the history of the advisory committee.
“I’m very aware of influenza vaccinations being a global enterprise, and companies manufacture vaccines for use in multiple countries,” said Committee Chair Kathryn Edwards, MD, professor of pediatrics at Vanderbilt University, Nashville, Tenn. “If we to select a B strain that differed from the WHO recommendation, would that adversely impact vaccine production for the U.S. market?”
Despite these questions, the committee continued to back the WHO recommendations.
Historically, the advisory committee has recommended flu vaccine strains earlier in the year, according to Beverly Taylor, PhD, head of influenza scientific affairs and pandemic readiness at Seqirus Vaccines. Dr. Taylor presented the vaccine manufacturers’ perspective. The delay has put added pressure on manufacturers.
“We haven’t seen impacts yet on start of vaccination dates,” said Dr. Taylor. “But the very clear message from manufacturers is if you keep squashing that manufacturing window, then there will reach a point where we are concerned we will see an impact on vaccine supply time.”
None of the committee members presented waivers of conflict of interest. While the FDA is not obligated to follow the recommendations of the advisory committee, it generally does.
ezimmerman@frontlinemedcom.com
On Twitter @EAZTweets
AT AN FDA ADVISORY COMMITTEE MEETING
Norovirus reporting tool yields real-time outbreak data
NoroSTAT, the Centers for Disease Control and Prevention’s new program with which states can report norovirus outbreaks, yields more timely and more complete epidemiologic and laboratory data, which allows a faster and better-informed public health response to such outbreaks, according to a report published in the Morbidity and Mortality Weekly Report.
The CDC launched NoroSTAT (Norovirus Sentinel Testing and Tracking) in 2012 to permit the health departments in selected states to report specific epidemiologic and laboratory data regarding norovirus outbreaks more rapidly than usual – within 7 business days, said Minesh P. Shah, MD, of the Epidemic Intelligence Service and the division of viral diseases, CDC, Atlanta, and his associates.
NoroSTAT significantly reduced the median interval in reporting epidemiologic data concerning norovirus from 22 days to 2 days and significantly reduced the median interval in reporting relevant laboratory data from 21 days to 3 days. The percentage of reports submitted within 7 business days increased from 26% to 95% among the states participating in NoroSTAT, while remaining low – only 12%-13% – in nonparticipating states. The number of complete reports also increased substantially, from 87% to 99.9%, among the participating states.
These improvements likely result from NoroSTAT’s stringent reporting requirements and from the program’s ability “to enhance communication between epidemiologists and laboratorians in both state health departments and at CDC,” Dr. Shah and his associates said (MMWR Morbidity and Mortality Weekly Report. 2017 Feb 24;66:185-9).
NoroSTAT represents a key advancement in norovirus outbreak surveillance and has proved valuable in early identification and better characterization of outbreaks. It was expanded to include nine states in August 2016, the investigators added.
NoroSTAT, the Centers for Disease Control and Prevention’s new program with which states can report norovirus outbreaks, yields more timely and more complete epidemiologic and laboratory data, which allows a faster and better-informed public health response to such outbreaks, according to a report published in the Morbidity and Mortality Weekly Report.
The CDC launched NoroSTAT (Norovirus Sentinel Testing and Tracking) in 2012 to permit the health departments in selected states to report specific epidemiologic and laboratory data regarding norovirus outbreaks more rapidly than usual – within 7 business days, said Minesh P. Shah, MD, of the Epidemic Intelligence Service and the division of viral diseases, CDC, Atlanta, and his associates.
NoroSTAT significantly reduced the median interval in reporting epidemiologic data concerning norovirus from 22 days to 2 days and significantly reduced the median interval in reporting relevant laboratory data from 21 days to 3 days. The percentage of reports submitted within 7 business days increased from 26% to 95% among the states participating in NoroSTAT, while remaining low – only 12%-13% – in nonparticipating states. The number of complete reports also increased substantially, from 87% to 99.9%, among the participating states.
These improvements likely result from NoroSTAT’s stringent reporting requirements and from the program’s ability “to enhance communication between epidemiologists and laboratorians in both state health departments and at CDC,” Dr. Shah and his associates said (MMWR Morbidity and Mortality Weekly Report. 2017 Feb 24;66:185-9).
NoroSTAT represents a key advancement in norovirus outbreak surveillance and has proved valuable in early identification and better characterization of outbreaks. It was expanded to include nine states in August 2016, the investigators added.
NoroSTAT, the Centers for Disease Control and Prevention’s new program with which states can report norovirus outbreaks, yields more timely and more complete epidemiologic and laboratory data, which allows a faster and better-informed public health response to such outbreaks, according to a report published in the Morbidity and Mortality Weekly Report.
The CDC launched NoroSTAT (Norovirus Sentinel Testing and Tracking) in 2012 to permit the health departments in selected states to report specific epidemiologic and laboratory data regarding norovirus outbreaks more rapidly than usual – within 7 business days, said Minesh P. Shah, MD, of the Epidemic Intelligence Service and the division of viral diseases, CDC, Atlanta, and his associates.
NoroSTAT significantly reduced the median interval in reporting epidemiologic data concerning norovirus from 22 days to 2 days and significantly reduced the median interval in reporting relevant laboratory data from 21 days to 3 days. The percentage of reports submitted within 7 business days increased from 26% to 95% among the states participating in NoroSTAT, while remaining low – only 12%-13% – in nonparticipating states. The number of complete reports also increased substantially, from 87% to 99.9%, among the participating states.
These improvements likely result from NoroSTAT’s stringent reporting requirements and from the program’s ability “to enhance communication between epidemiologists and laboratorians in both state health departments and at CDC,” Dr. Shah and his associates said (MMWR Morbidity and Mortality Weekly Report. 2017 Feb 24;66:185-9).
NoroSTAT represents a key advancement in norovirus outbreak surveillance and has proved valuable in early identification and better characterization of outbreaks. It was expanded to include nine states in August 2016, the investigators added.
Key clinical point: NoroSTAT, the CDC’s new program with which states can report norovirus outbreaks, yields more timely and complete epidemiologic data.
Major finding: NoroSTAT significantly reduced the median interval in reporting epidemiologic data concerning norovirus from 22 days to 2 days and significantly reduced the median interval in reporting relevant laboratory data from 21 days to 3 days.
Data source: A comparison of epidemiologic and laboratory data reported by all 50 states for the 3 years before and the 3 years after NoroSTAT was implemented in 5 states.
Disclosures: This study was sponsored by the Centers for Disease Control and Prevention. No financial disclosures were provided.
FDA approves first dedicated bifurcation device to treat coronary bifurcation lesions
Tryton Medical announced on March 6 that the Food and Drug Administration has approved Tryton Side Branch Stent for the treatment of coronary bifurcation lesions involving large side branches, becoming the first dedicated bifurcation device to receive regulatory approval in the U.S.
In a post hoc analysis of a randomized clinical trial, treatment with the Tryton Side Branch Stent in the intended population of patients with large side branches (stent greater than 2.5mm) reduced the need for additional bailout stenting (0.7% vs. 5.6%, P = .02). It led to significantly lower side branch percent diameter stenosis at a 9-month follow-up (30.4% vs. 40.6%, P = .004) when compared with provisional stenting. The analysis also showed comparable major adverse cardiovascular events and myocardial infarction rates when compared with provisional stenting at 3 years.
“Treatment of complex lesions at the site of a bifurcation has historically been inconsistent, with results varying depending on the procedure and the experience of the interventionist,” said Aaron Kaplan, MD, Professor of Medicine at Dartmouth Hitchcock Medical Center, Lebanon, N.H., and Chief Medical Officer of Tryton Medical, in a press release. “A predictable bifurcation solution helps alleviate some of the stress in these procedures by limiting variability and reducing the need for bailout stenting. This important FDA decision could have a profound impact on treatment protocols and guidelines for significant bifurcation lesions in the years ahead.”
There have been no randomized studies to compare the results of percutaneous coronary interventions (PCI) with coronary artery bypass grafting in a bifurcation-only patient population. But this new device should benefit results from treatment using PCI.
Coronary artery disease is the leading cause of death in the U.S. in both men and women, and often results in bifurcation. Provisional stenting of the main branch is the current standard of care, but in many cases the side branch is not stented, leaving it vulnerable to complications like occlusion requiring bailout stenting.
Read more on Tryton Side Branch Stent on Tryton’s website.
Tryton Medical announced on March 6 that the Food and Drug Administration has approved Tryton Side Branch Stent for the treatment of coronary bifurcation lesions involving large side branches, becoming the first dedicated bifurcation device to receive regulatory approval in the U.S.
In a post hoc analysis of a randomized clinical trial, treatment with the Tryton Side Branch Stent in the intended population of patients with large side branches (stent greater than 2.5mm) reduced the need for additional bailout stenting (0.7% vs. 5.6%, P = .02). It led to significantly lower side branch percent diameter stenosis at a 9-month follow-up (30.4% vs. 40.6%, P = .004) when compared with provisional stenting. The analysis also showed comparable major adverse cardiovascular events and myocardial infarction rates when compared with provisional stenting at 3 years.
“Treatment of complex lesions at the site of a bifurcation has historically been inconsistent, with results varying depending on the procedure and the experience of the interventionist,” said Aaron Kaplan, MD, Professor of Medicine at Dartmouth Hitchcock Medical Center, Lebanon, N.H., and Chief Medical Officer of Tryton Medical, in a press release. “A predictable bifurcation solution helps alleviate some of the stress in these procedures by limiting variability and reducing the need for bailout stenting. This important FDA decision could have a profound impact on treatment protocols and guidelines for significant bifurcation lesions in the years ahead.”
There have been no randomized studies to compare the results of percutaneous coronary interventions (PCI) with coronary artery bypass grafting in a bifurcation-only patient population. But this new device should benefit results from treatment using PCI.
Coronary artery disease is the leading cause of death in the U.S. in both men and women, and often results in bifurcation. Provisional stenting of the main branch is the current standard of care, but in many cases the side branch is not stented, leaving it vulnerable to complications like occlusion requiring bailout stenting.
Read more on Tryton Side Branch Stent on Tryton’s website.
Tryton Medical announced on March 6 that the Food and Drug Administration has approved Tryton Side Branch Stent for the treatment of coronary bifurcation lesions involving large side branches, becoming the first dedicated bifurcation device to receive regulatory approval in the U.S.
In a post hoc analysis of a randomized clinical trial, treatment with the Tryton Side Branch Stent in the intended population of patients with large side branches (stent greater than 2.5mm) reduced the need for additional bailout stenting (0.7% vs. 5.6%, P = .02). It led to significantly lower side branch percent diameter stenosis at a 9-month follow-up (30.4% vs. 40.6%, P = .004) when compared with provisional stenting. The analysis also showed comparable major adverse cardiovascular events and myocardial infarction rates when compared with provisional stenting at 3 years.
“Treatment of complex lesions at the site of a bifurcation has historically been inconsistent, with results varying depending on the procedure and the experience of the interventionist,” said Aaron Kaplan, MD, Professor of Medicine at Dartmouth Hitchcock Medical Center, Lebanon, N.H., and Chief Medical Officer of Tryton Medical, in a press release. “A predictable bifurcation solution helps alleviate some of the stress in these procedures by limiting variability and reducing the need for bailout stenting. This important FDA decision could have a profound impact on treatment protocols and guidelines for significant bifurcation lesions in the years ahead.”
There have been no randomized studies to compare the results of percutaneous coronary interventions (PCI) with coronary artery bypass grafting in a bifurcation-only patient population. But this new device should benefit results from treatment using PCI.
Coronary artery disease is the leading cause of death in the U.S. in both men and women, and often results in bifurcation. Provisional stenting of the main branch is the current standard of care, but in many cases the side branch is not stented, leaving it vulnerable to complications like occlusion requiring bailout stenting.
Read more on Tryton Side Branch Stent on Tryton’s website.
CDC: Greater activity limitations accompany rising arthritis prevalence
The number of adults with arthritis in the United States continues to rise, with the number projected to climb as high as 78 million by the year 2040. Some of the keys to stemming this rising tide are exercise, along with greater knowledge of how to manage symptoms, according to a new report from the Centers for Disease Control and Prevention.
“Arthritis is at an all-time high: more than 54 million people report a diagnosis of it, and alarmingly, more people with arthritis are suffering from it,” said Anne Schuchat, MD, acting director of the CDC, during a conference call regarding the agency’s latest Vital Signs report (MMWR Morb Mortal Wkly Rep. 2017 Mar 7. doi: org/10.15585/mmwr.mm6609e1). “Among adults with arthritis, the percentage whose lives are particularly limited has increased by about 20% since 2002, from about 36% in 2002 to 43% in 2015. We’re seeing this increase independent of aging of the population.”
“Physical activity can be the antidote for many people [and] can actually decrease pain and improve function by almost 40%,” Dr. Schuchat explained. “Right now, one in three adults with arthritis report being inactive [because of] pain or fear of pain or not knowing what exercise is safe for their joints.”
This inactivity can lead to arthritis patients developing other serious chronic conditions, such as heart disease, diabetes and obesity – conditions that all require physical activity in order to properly manage them. Arthritis alone puts an extraordinary financial burden on the domestic health care industry, as direct medical costs associated with the condition total roughly $81 billion per year, according to the CDC. Additionally, about half of all adults with heart disease or diabetes, and about one-third of obese adults, also have arthritis.
In addition to engaging in regular physical activity, the Vital Signs report also recommends that arthritis patients attend disease management education programs, which are available regionally but often go underutilized, largely due to lack of awareness about them or trepidation regarding how effective the programs really are. To combat this, the CDC is calling on health care providers to help them educate patients about these classes and spread the word about the steps that can be taken to manage arthritis. In 2017, the CDC is funding arthritis programs in 12 states (California, Kansas, Kentucky, Michigan, Missouri, Montana, New York, Oregon, Pennsylvania, Rhode Island, South Carolina, and Utah) to disseminate arthritis-appropriate evidence-based physical activity and self-management education interventions.
“Men or women with arthritis can reduce their symptoms by 10%-20% by participating in disease management education programs to acquire skills to better manage their symptoms. Right now, these programs are only reaching about 1 in 10 people with arthritis, but the classes are available in many community settings,” Dr. Schuchat said. “We know that adults with arthritis are significantly more likely to attend a disease management education program when a health care provider recommends it to them.”
When seeing patients with arthritis, Dr. Schuchat advised health care providers to recommend routine physical activity, such as walking, biking, swimming, and physical activity programs offered by local parks and recreation centers, as well as weight loss, in order to ease joint pain. The American College of Rheumatology and other professional organizations provide guidelines for discussing treatment options with patients. Providing treatment or additional services for depression or anxiety, which occur in about one-third of adult arthritis patients, may help individuals to better manage their arthritis symptoms.
The agency’s report derives from its analysis of 2013-2015 data from the National Health Interview Survey, which comprised a nationally representative sample of about 36,000 in-person interviews. The survey classifies individuals with physician-diagnosed arthritis as those who answered “yes” to the question “Have you ever been told by a doctor or other health professional that you have some form of arthritis, rheumatoid arthritis, gout, lupus, or fibromyalgia?”
The number of adults with arthritis in the United States continues to rise, with the number projected to climb as high as 78 million by the year 2040. Some of the keys to stemming this rising tide are exercise, along with greater knowledge of how to manage symptoms, according to a new report from the Centers for Disease Control and Prevention.
“Arthritis is at an all-time high: more than 54 million people report a diagnosis of it, and alarmingly, more people with arthritis are suffering from it,” said Anne Schuchat, MD, acting director of the CDC, during a conference call regarding the agency’s latest Vital Signs report (MMWR Morb Mortal Wkly Rep. 2017 Mar 7. doi: org/10.15585/mmwr.mm6609e1). “Among adults with arthritis, the percentage whose lives are particularly limited has increased by about 20% since 2002, from about 36% in 2002 to 43% in 2015. We’re seeing this increase independent of aging of the population.”
“Physical activity can be the antidote for many people [and] can actually decrease pain and improve function by almost 40%,” Dr. Schuchat explained. “Right now, one in three adults with arthritis report being inactive [because of] pain or fear of pain or not knowing what exercise is safe for their joints.”
This inactivity can lead to arthritis patients developing other serious chronic conditions, such as heart disease, diabetes and obesity – conditions that all require physical activity in order to properly manage them. Arthritis alone puts an extraordinary financial burden on the domestic health care industry, as direct medical costs associated with the condition total roughly $81 billion per year, according to the CDC. Additionally, about half of all adults with heart disease or diabetes, and about one-third of obese adults, also have arthritis.
In addition to engaging in regular physical activity, the Vital Signs report also recommends that arthritis patients attend disease management education programs, which are available regionally but often go underutilized, largely due to lack of awareness about them or trepidation regarding how effective the programs really are. To combat this, the CDC is calling on health care providers to help them educate patients about these classes and spread the word about the steps that can be taken to manage arthritis. In 2017, the CDC is funding arthritis programs in 12 states (California, Kansas, Kentucky, Michigan, Missouri, Montana, New York, Oregon, Pennsylvania, Rhode Island, South Carolina, and Utah) to disseminate arthritis-appropriate evidence-based physical activity and self-management education interventions.
“Men or women with arthritis can reduce their symptoms by 10%-20% by participating in disease management education programs to acquire skills to better manage their symptoms. Right now, these programs are only reaching about 1 in 10 people with arthritis, but the classes are available in many community settings,” Dr. Schuchat said. “We know that adults with arthritis are significantly more likely to attend a disease management education program when a health care provider recommends it to them.”
When seeing patients with arthritis, Dr. Schuchat advised health care providers to recommend routine physical activity, such as walking, biking, swimming, and physical activity programs offered by local parks and recreation centers, as well as weight loss, in order to ease joint pain. The American College of Rheumatology and other professional organizations provide guidelines for discussing treatment options with patients. Providing treatment or additional services for depression or anxiety, which occur in about one-third of adult arthritis patients, may help individuals to better manage their arthritis symptoms.
The agency’s report derives from its analysis of 2013-2015 data from the National Health Interview Survey, which comprised a nationally representative sample of about 36,000 in-person interviews. The survey classifies individuals with physician-diagnosed arthritis as those who answered “yes” to the question “Have you ever been told by a doctor or other health professional that you have some form of arthritis, rheumatoid arthritis, gout, lupus, or fibromyalgia?”
The number of adults with arthritis in the United States continues to rise, with the number projected to climb as high as 78 million by the year 2040. Some of the keys to stemming this rising tide are exercise, along with greater knowledge of how to manage symptoms, according to a new report from the Centers for Disease Control and Prevention.
“Arthritis is at an all-time high: more than 54 million people report a diagnosis of it, and alarmingly, more people with arthritis are suffering from it,” said Anne Schuchat, MD, acting director of the CDC, during a conference call regarding the agency’s latest Vital Signs report (MMWR Morb Mortal Wkly Rep. 2017 Mar 7. doi: org/10.15585/mmwr.mm6609e1). “Among adults with arthritis, the percentage whose lives are particularly limited has increased by about 20% since 2002, from about 36% in 2002 to 43% in 2015. We’re seeing this increase independent of aging of the population.”
“Physical activity can be the antidote for many people [and] can actually decrease pain and improve function by almost 40%,” Dr. Schuchat explained. “Right now, one in three adults with arthritis report being inactive [because of] pain or fear of pain or not knowing what exercise is safe for their joints.”
This inactivity can lead to arthritis patients developing other serious chronic conditions, such as heart disease, diabetes and obesity – conditions that all require physical activity in order to properly manage them. Arthritis alone puts an extraordinary financial burden on the domestic health care industry, as direct medical costs associated with the condition total roughly $81 billion per year, according to the CDC. Additionally, about half of all adults with heart disease or diabetes, and about one-third of obese adults, also have arthritis.
In addition to engaging in regular physical activity, the Vital Signs report also recommends that arthritis patients attend disease management education programs, which are available regionally but often go underutilized, largely due to lack of awareness about them or trepidation regarding how effective the programs really are. To combat this, the CDC is calling on health care providers to help them educate patients about these classes and spread the word about the steps that can be taken to manage arthritis. In 2017, the CDC is funding arthritis programs in 12 states (California, Kansas, Kentucky, Michigan, Missouri, Montana, New York, Oregon, Pennsylvania, Rhode Island, South Carolina, and Utah) to disseminate arthritis-appropriate evidence-based physical activity and self-management education interventions.
“Men or women with arthritis can reduce their symptoms by 10%-20% by participating in disease management education programs to acquire skills to better manage their symptoms. Right now, these programs are only reaching about 1 in 10 people with arthritis, but the classes are available in many community settings,” Dr. Schuchat said. “We know that adults with arthritis are significantly more likely to attend a disease management education program when a health care provider recommends it to them.”
When seeing patients with arthritis, Dr. Schuchat advised health care providers to recommend routine physical activity, such as walking, biking, swimming, and physical activity programs offered by local parks and recreation centers, as well as weight loss, in order to ease joint pain. The American College of Rheumatology and other professional organizations provide guidelines for discussing treatment options with patients. Providing treatment or additional services for depression or anxiety, which occur in about one-third of adult arthritis patients, may help individuals to better manage their arthritis symptoms.
The agency’s report derives from its analysis of 2013-2015 data from the National Health Interview Survey, which comprised a nationally representative sample of about 36,000 in-person interviews. The survey classifies individuals with physician-diagnosed arthritis as those who answered “yes” to the question “Have you ever been told by a doctor or other health professional that you have some form of arthritis, rheumatoid arthritis, gout, lupus, or fibromyalgia?”
FROM MMWR
Key clinical point:
Major finding: About 24 million American adults report being significantly limited due to their arthritis.
Data source: 2013-2015 data from the National Health Interview Survey.
Disclosures: No disclosures were reported.
FDA approves miniature heart pump for use during high risk PCI
A miniature heart pump has been approved by the Food and Drug Administration to “help certain patients maintain stable heart function and circulation during certain high-risk percutaneous coronary intervention (HRPCI) procedures,” the agency has announced.
The Impella 2.5 System, manufactured by Abiomed, is “intended for temporary use by patients with severe symptomatic CAD [coronary artery disease] and diminished (but stable) heart function who are undergoing HRPCI but are not candidates for surgical coronary bypass treatment,” according to the FDA’s statement.
“Use of the Impella 2.5 System is intended to prevent episodes of unstable heart function, including unstable blood pressure and poor circulation, in patients who are at high risk for its occurrence,” Dr. William Maisel, acting director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health, said in the statement.
Approval was based on the PROTECT II study and observational data from the USpella Registry.
“The overall data provided evidence that, for patients with severe CAD and diminished heart function, the temporary circulatory support provided by the Impella 2.5 System during an HRPCI procedure may allow a longer and more thorough procedure by preventing episodes of hemodynamic instability ... due to temporary abnormalities in heart function,” the FDA statement said. In addition, “fewer later adverse events” such as the need for repeat HRPCI procedures, “may occur in patients undergoing HRPCI with the pump compared to patients undergoing HRPCI with an intra-aortic balloon pump,” according to the FDA.
The FDA statement also noted that the system can be used as an alternative to the intra-aortic balloon pump “without significantly increasing the safety risks of the HRPCI procedure.”
As a postmarketing requirement, the manufacturer will conduct a single arm study of the device in high-risk PCI patients, according to the company’s statement announcing approval.
The wording of the approved indication is as follows, according to Abiomed: “The Impella 2.5 is a temporary (less than or equal to 6 hours) ventricular support device indicated for use during high-risk PCI performed in elective or urgent hemodynamically stable patients with severe coronary artery disease and depressed left ventricular ejection fraction, when a heart team, including a cardiac surgeon, has determined high-risk PCI is the appropriate therapeutic option. Use of the Impella 2.5 in these patients may prevent hemodynamic instability that may occur during planned temporary coronary occlusions and may reduce peri- and postprocedural adverse events.”
A miniature heart pump has been approved by the Food and Drug Administration to “help certain patients maintain stable heart function and circulation during certain high-risk percutaneous coronary intervention (HRPCI) procedures,” the agency has announced.
The Impella 2.5 System, manufactured by Abiomed, is “intended for temporary use by patients with severe symptomatic CAD [coronary artery disease] and diminished (but stable) heart function who are undergoing HRPCI but are not candidates for surgical coronary bypass treatment,” according to the FDA’s statement.
“Use of the Impella 2.5 System is intended to prevent episodes of unstable heart function, including unstable blood pressure and poor circulation, in patients who are at high risk for its occurrence,” Dr. William Maisel, acting director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health, said in the statement.
Approval was based on the PROTECT II study and observational data from the USpella Registry.
“The overall data provided evidence that, for patients with severe CAD and diminished heart function, the temporary circulatory support provided by the Impella 2.5 System during an HRPCI procedure may allow a longer and more thorough procedure by preventing episodes of hemodynamic instability ... due to temporary abnormalities in heart function,” the FDA statement said. In addition, “fewer later adverse events” such as the need for repeat HRPCI procedures, “may occur in patients undergoing HRPCI with the pump compared to patients undergoing HRPCI with an intra-aortic balloon pump,” according to the FDA.
The FDA statement also noted that the system can be used as an alternative to the intra-aortic balloon pump “without significantly increasing the safety risks of the HRPCI procedure.”
As a postmarketing requirement, the manufacturer will conduct a single arm study of the device in high-risk PCI patients, according to the company’s statement announcing approval.
The wording of the approved indication is as follows, according to Abiomed: “The Impella 2.5 is a temporary (less than or equal to 6 hours) ventricular support device indicated for use during high-risk PCI performed in elective or urgent hemodynamically stable patients with severe coronary artery disease and depressed left ventricular ejection fraction, when a heart team, including a cardiac surgeon, has determined high-risk PCI is the appropriate therapeutic option. Use of the Impella 2.5 in these patients may prevent hemodynamic instability that may occur during planned temporary coronary occlusions and may reduce peri- and postprocedural adverse events.”
A miniature heart pump has been approved by the Food and Drug Administration to “help certain patients maintain stable heart function and circulation during certain high-risk percutaneous coronary intervention (HRPCI) procedures,” the agency has announced.
The Impella 2.5 System, manufactured by Abiomed, is “intended for temporary use by patients with severe symptomatic CAD [coronary artery disease] and diminished (but stable) heart function who are undergoing HRPCI but are not candidates for surgical coronary bypass treatment,” according to the FDA’s statement.
“Use of the Impella 2.5 System is intended to prevent episodes of unstable heart function, including unstable blood pressure and poor circulation, in patients who are at high risk for its occurrence,” Dr. William Maisel, acting director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health, said in the statement.
Approval was based on the PROTECT II study and observational data from the USpella Registry.
“The overall data provided evidence that, for patients with severe CAD and diminished heart function, the temporary circulatory support provided by the Impella 2.5 System during an HRPCI procedure may allow a longer and more thorough procedure by preventing episodes of hemodynamic instability ... due to temporary abnormalities in heart function,” the FDA statement said. In addition, “fewer later adverse events” such as the need for repeat HRPCI procedures, “may occur in patients undergoing HRPCI with the pump compared to patients undergoing HRPCI with an intra-aortic balloon pump,” according to the FDA.
The FDA statement also noted that the system can be used as an alternative to the intra-aortic balloon pump “without significantly increasing the safety risks of the HRPCI procedure.”
As a postmarketing requirement, the manufacturer will conduct a single arm study of the device in high-risk PCI patients, according to the company’s statement announcing approval.
The wording of the approved indication is as follows, according to Abiomed: “The Impella 2.5 is a temporary (less than or equal to 6 hours) ventricular support device indicated for use during high-risk PCI performed in elective or urgent hemodynamically stable patients with severe coronary artery disease and depressed left ventricular ejection fraction, when a heart team, including a cardiac surgeon, has determined high-risk PCI is the appropriate therapeutic option. Use of the Impella 2.5 in these patients may prevent hemodynamic instability that may occur during planned temporary coronary occlusions and may reduce peri- and postprocedural adverse events.”
