User login
E-cigarette users topped 8 million in 2018
according to a report from the National Center for Health Statistics.
Those 8.1 million individuals who were using e-cigarettes either every day or some days represented 3.2% of the total adult population, based on data from the 2018 National Health Interview Survey. An even larger proportion, 14.9%, said that they had at least tried an e-cigarette, Maria A. Villarroel, PhD, and associates at the NCHS said in a recent data brief.
Most cigarette smokers, both current and former, were even more likely to use e-cigarettes, they noted.
Former cigarette smokers who had quit within the last year were the most likely to use e-cigarettes – 57.3% had ever used one and 25.2% were current users – while current cigarette users (49.4% ever use and 9.7% current use) and former smokers who had quit 1-5 years before (48.6% ever use, 17.3% current) also were above-average e-cigarette consumers, they reported.
Use was significantly lower, however, among former cigarette smokers who had quit 5 or more years earlier (9.0% and 1.7%, respectively) and those who had never smoked (6.5% and 1.1%), the NCHS investigators said.
The survey data also showed much variation among the sociodemographic subgroups:
- E-cigarette ever/current use was significantly higher in men (17.9% and 4.2%) than women (12.3% and 2.3%).
- Whites were significantly more likely to use e-cigarettes (16.9% and 3.7%), compared with Hispanic (11.5% and 2.5%), black (10.0% and 1.6%), and Asian (10.2% and 2.2%) adults.
- There was significant trend of decreasing use from age 18-24 years (25.8% and 7.6%) to 65 years and older (4.7% and 0.8%).
SOURCE: Villarroel MA et al. NCHS Data Brief No. 365, April 2020.
according to a report from the National Center for Health Statistics.
Those 8.1 million individuals who were using e-cigarettes either every day or some days represented 3.2% of the total adult population, based on data from the 2018 National Health Interview Survey. An even larger proportion, 14.9%, said that they had at least tried an e-cigarette, Maria A. Villarroel, PhD, and associates at the NCHS said in a recent data brief.
Most cigarette smokers, both current and former, were even more likely to use e-cigarettes, they noted.
Former cigarette smokers who had quit within the last year were the most likely to use e-cigarettes – 57.3% had ever used one and 25.2% were current users – while current cigarette users (49.4% ever use and 9.7% current use) and former smokers who had quit 1-5 years before (48.6% ever use, 17.3% current) also were above-average e-cigarette consumers, they reported.
Use was significantly lower, however, among former cigarette smokers who had quit 5 or more years earlier (9.0% and 1.7%, respectively) and those who had never smoked (6.5% and 1.1%), the NCHS investigators said.
The survey data also showed much variation among the sociodemographic subgroups:
- E-cigarette ever/current use was significantly higher in men (17.9% and 4.2%) than women (12.3% and 2.3%).
- Whites were significantly more likely to use e-cigarettes (16.9% and 3.7%), compared with Hispanic (11.5% and 2.5%), black (10.0% and 1.6%), and Asian (10.2% and 2.2%) adults.
- There was significant trend of decreasing use from age 18-24 years (25.8% and 7.6%) to 65 years and older (4.7% and 0.8%).
SOURCE: Villarroel MA et al. NCHS Data Brief No. 365, April 2020.
according to a report from the National Center for Health Statistics.
Those 8.1 million individuals who were using e-cigarettes either every day or some days represented 3.2% of the total adult population, based on data from the 2018 National Health Interview Survey. An even larger proportion, 14.9%, said that they had at least tried an e-cigarette, Maria A. Villarroel, PhD, and associates at the NCHS said in a recent data brief.
Most cigarette smokers, both current and former, were even more likely to use e-cigarettes, they noted.
Former cigarette smokers who had quit within the last year were the most likely to use e-cigarettes – 57.3% had ever used one and 25.2% were current users – while current cigarette users (49.4% ever use and 9.7% current use) and former smokers who had quit 1-5 years before (48.6% ever use, 17.3% current) also were above-average e-cigarette consumers, they reported.
Use was significantly lower, however, among former cigarette smokers who had quit 5 or more years earlier (9.0% and 1.7%, respectively) and those who had never smoked (6.5% and 1.1%), the NCHS investigators said.
The survey data also showed much variation among the sociodemographic subgroups:
- E-cigarette ever/current use was significantly higher in men (17.9% and 4.2%) than women (12.3% and 2.3%).
- Whites were significantly more likely to use e-cigarettes (16.9% and 3.7%), compared with Hispanic (11.5% and 2.5%), black (10.0% and 1.6%), and Asian (10.2% and 2.2%) adults.
- There was significant trend of decreasing use from age 18-24 years (25.8% and 7.6%) to 65 years and older (4.7% and 0.8%).
SOURCE: Villarroel MA et al. NCHS Data Brief No. 365, April 2020.
Operation Quack Hack: FDA moves to stop fraudulent COVID-19 products
No form of human misery can be allowed to go unexploited, and the pandemic, it seems, is no exception.
As part of Operation Quack Hack, the Food and Drug Administration has stepped up its investigation and enforcement efforts against companies and individuals that are “taking advantage of widespread fear among consumers during the COVID-19 pandemic” by selling fake products and treatments for coronavirus.
As of May 7, 2020, the agency had issued 42 warning letters to companies that were “selling unapproved products that fraudulently claim to mitigate, prevent, treat, diagnose or cure COVID-19,” the FDA announced in a written statement. Of those 42 products, 29 are no longer being sold with any sort of COVID-19 claim.
Since the beginning of the pandemic, Operation Quack Hack has uncovered hundreds of such products – drugs, testing kits, and personal protective equipment – being sold online, and complaints were sent to domain-name registrars and Internet marketplaces that have, in most cases, removed the postings, the FDA said.
“We will continue to monitor the online ecosystem for fraudulent products peddled by bad actors seeking to profit from this global pandemic. We encourage anyone aware of suspected fraudulent medical products for COVID-19 to report them to the FDA,” the statement said.
No form of human misery can be allowed to go unexploited, and the pandemic, it seems, is no exception.
As part of Operation Quack Hack, the Food and Drug Administration has stepped up its investigation and enforcement efforts against companies and individuals that are “taking advantage of widespread fear among consumers during the COVID-19 pandemic” by selling fake products and treatments for coronavirus.
As of May 7, 2020, the agency had issued 42 warning letters to companies that were “selling unapproved products that fraudulently claim to mitigate, prevent, treat, diagnose or cure COVID-19,” the FDA announced in a written statement. Of those 42 products, 29 are no longer being sold with any sort of COVID-19 claim.
Since the beginning of the pandemic, Operation Quack Hack has uncovered hundreds of such products – drugs, testing kits, and personal protective equipment – being sold online, and complaints were sent to domain-name registrars and Internet marketplaces that have, in most cases, removed the postings, the FDA said.
“We will continue to monitor the online ecosystem for fraudulent products peddled by bad actors seeking to profit from this global pandemic. We encourage anyone aware of suspected fraudulent medical products for COVID-19 to report them to the FDA,” the statement said.
No form of human misery can be allowed to go unexploited, and the pandemic, it seems, is no exception.
As part of Operation Quack Hack, the Food and Drug Administration has stepped up its investigation and enforcement efforts against companies and individuals that are “taking advantage of widespread fear among consumers during the COVID-19 pandemic” by selling fake products and treatments for coronavirus.
As of May 7, 2020, the agency had issued 42 warning letters to companies that were “selling unapproved products that fraudulently claim to mitigate, prevent, treat, diagnose or cure COVID-19,” the FDA announced in a written statement. Of those 42 products, 29 are no longer being sold with any sort of COVID-19 claim.
Since the beginning of the pandemic, Operation Quack Hack has uncovered hundreds of such products – drugs, testing kits, and personal protective equipment – being sold online, and complaints were sent to domain-name registrars and Internet marketplaces that have, in most cases, removed the postings, the FDA said.
“We will continue to monitor the online ecosystem for fraudulent products peddled by bad actors seeking to profit from this global pandemic. We encourage anyone aware of suspected fraudulent medical products for COVID-19 to report them to the FDA,” the statement said.
NSCLC: FDA approves capmatinib and companion assay
as detected by an FDA-approved test.
The FDA also approved the FoundationOne CDx assay (F1CDx) as a companion diagnostic for capmatinib. F1CDx is a next-generation sequencing-based, in vitro diagnostic device that detects several mutations, including MET exon 14 skipping mutations.
Capmatinib is a selective, reversible inhibitor of MET tyrosine kinase and the first treatment FDA-approved for NSCLC with MET exon 14 skipping mutations.
Capmatinib was granted accelerated approval based on overall response rate and response duration in the GEOMETRY mono-1 trial, the FDA said. Results from this trial were recently presented at the AACR Virtual Annual Meeting I.
The phase 2 trial enrolled 97 patients with metastatic NSCLC and confirmed MET exon 14 skipping mutations, 69 of whom were previously treated and 28 of whom were treatment naive. The patients received capmatinib at 400 mg orally twice daily until disease progression or unacceptable toxicity.
The overall response rate was 68% in the treatment-naive patients and 41% in the previously treated patients. The median duration of response was 12.6 months and 9.7 months, respectively, according to the FDA.
The most common adverse events (occurring in at least 20% of patients) were peripheral edema, nausea, fatigue, vomiting, dyspnea, and decreased appetite.
The full prescribing information for capmatinib is available for download from the FDA website.
The FDA granted the approval of capmatinib to Novartis Pharmaceuticals Corporation and the approval of the F1CDx companion diagnostic to Foundation Medicine.
as detected by an FDA-approved test.
The FDA also approved the FoundationOne CDx assay (F1CDx) as a companion diagnostic for capmatinib. F1CDx is a next-generation sequencing-based, in vitro diagnostic device that detects several mutations, including MET exon 14 skipping mutations.
Capmatinib is a selective, reversible inhibitor of MET tyrosine kinase and the first treatment FDA-approved for NSCLC with MET exon 14 skipping mutations.
Capmatinib was granted accelerated approval based on overall response rate and response duration in the GEOMETRY mono-1 trial, the FDA said. Results from this trial were recently presented at the AACR Virtual Annual Meeting I.
The phase 2 trial enrolled 97 patients with metastatic NSCLC and confirmed MET exon 14 skipping mutations, 69 of whom were previously treated and 28 of whom were treatment naive. The patients received capmatinib at 400 mg orally twice daily until disease progression or unacceptable toxicity.
The overall response rate was 68% in the treatment-naive patients and 41% in the previously treated patients. The median duration of response was 12.6 months and 9.7 months, respectively, according to the FDA.
The most common adverse events (occurring in at least 20% of patients) were peripheral edema, nausea, fatigue, vomiting, dyspnea, and decreased appetite.
The full prescribing information for capmatinib is available for download from the FDA website.
The FDA granted the approval of capmatinib to Novartis Pharmaceuticals Corporation and the approval of the F1CDx companion diagnostic to Foundation Medicine.
as detected by an FDA-approved test.
The FDA also approved the FoundationOne CDx assay (F1CDx) as a companion diagnostic for capmatinib. F1CDx is a next-generation sequencing-based, in vitro diagnostic device that detects several mutations, including MET exon 14 skipping mutations.
Capmatinib is a selective, reversible inhibitor of MET tyrosine kinase and the first treatment FDA-approved for NSCLC with MET exon 14 skipping mutations.
Capmatinib was granted accelerated approval based on overall response rate and response duration in the GEOMETRY mono-1 trial, the FDA said. Results from this trial were recently presented at the AACR Virtual Annual Meeting I.
The phase 2 trial enrolled 97 patients with metastatic NSCLC and confirmed MET exon 14 skipping mutations, 69 of whom were previously treated and 28 of whom were treatment naive. The patients received capmatinib at 400 mg orally twice daily until disease progression or unacceptable toxicity.
The overall response rate was 68% in the treatment-naive patients and 41% in the previously treated patients. The median duration of response was 12.6 months and 9.7 months, respectively, according to the FDA.
The most common adverse events (occurring in at least 20% of patients) were peripheral edema, nausea, fatigue, vomiting, dyspnea, and decreased appetite.
The full prescribing information for capmatinib is available for download from the FDA website.
The FDA granted the approval of capmatinib to Novartis Pharmaceuticals Corporation and the approval of the F1CDx companion diagnostic to Foundation Medicine.
FDA grants EUA to muscle stimulator to reduce mechanical ventilator usage
The Food and Drug Administration has issued an Emergency Use Authorization (EUA) for the VentFree Respiratory Muscle Stimulator in order to potentially reduce the number of days adult patients, including those with COVID-19, require mechanical ventilation, according to a press release from Liberate Medical.
In comparison with mechanical ventilation, which is invasive and commonly weakens the breathing muscles, the VentFree system uses noninvasive neuromuscular electrical stimulation to contract the abdominal wall muscles in synchrony with exhalation during mechanical ventilation, according to the press release. This allows patients to begin treatment during the early stages of ventilation while they are sedated and to continue until they are weaned off of ventilation.
A pair of pilot randomized, controlled studies, completed in Europe and Australia, showed that VentFree helped to reduce ventilation duration and ICU length of stay, compared with placebo stimulation. The FDA granted VentFree Breakthrough Device status in 2019.
“We are grateful to the FDA for recognizing the potential of VentFree and feel privileged to have the opportunity to help patients on mechanical ventilation during the COVID-19 pandemic,” Angus McLachlan PhD, cofounder and CEO of Liberate Medical, said in the press release.
VentFree has been authorized for use only for the duration of the current COVID-19 emergency, as it has not yet been approved or cleared for usage by primary care providers.
The Food and Drug Administration has issued an Emergency Use Authorization (EUA) for the VentFree Respiratory Muscle Stimulator in order to potentially reduce the number of days adult patients, including those with COVID-19, require mechanical ventilation, according to a press release from Liberate Medical.
In comparison with mechanical ventilation, which is invasive and commonly weakens the breathing muscles, the VentFree system uses noninvasive neuromuscular electrical stimulation to contract the abdominal wall muscles in synchrony with exhalation during mechanical ventilation, according to the press release. This allows patients to begin treatment during the early stages of ventilation while they are sedated and to continue until they are weaned off of ventilation.
A pair of pilot randomized, controlled studies, completed in Europe and Australia, showed that VentFree helped to reduce ventilation duration and ICU length of stay, compared with placebo stimulation. The FDA granted VentFree Breakthrough Device status in 2019.
“We are grateful to the FDA for recognizing the potential of VentFree and feel privileged to have the opportunity to help patients on mechanical ventilation during the COVID-19 pandemic,” Angus McLachlan PhD, cofounder and CEO of Liberate Medical, said in the press release.
VentFree has been authorized for use only for the duration of the current COVID-19 emergency, as it has not yet been approved or cleared for usage by primary care providers.
The Food and Drug Administration has issued an Emergency Use Authorization (EUA) for the VentFree Respiratory Muscle Stimulator in order to potentially reduce the number of days adult patients, including those with COVID-19, require mechanical ventilation, according to a press release from Liberate Medical.
In comparison with mechanical ventilation, which is invasive and commonly weakens the breathing muscles, the VentFree system uses noninvasive neuromuscular electrical stimulation to contract the abdominal wall muscles in synchrony with exhalation during mechanical ventilation, according to the press release. This allows patients to begin treatment during the early stages of ventilation while they are sedated and to continue until they are weaned off of ventilation.
A pair of pilot randomized, controlled studies, completed in Europe and Australia, showed that VentFree helped to reduce ventilation duration and ICU length of stay, compared with placebo stimulation. The FDA granted VentFree Breakthrough Device status in 2019.
“We are grateful to the FDA for recognizing the potential of VentFree and feel privileged to have the opportunity to help patients on mechanical ventilation during the COVID-19 pandemic,” Angus McLachlan PhD, cofounder and CEO of Liberate Medical, said in the press release.
VentFree has been authorized for use only for the duration of the current COVID-19 emergency, as it has not yet been approved or cleared for usage by primary care providers.
FDA tightens requirements for COVID-19 antibody tests
The U.S. Food and Drug Administration is tightening requirements for companies that develop COVID-19 antibody tests in an effort to combat fraud and better regulate the frenzy of tests coming to market.
The updated policy, announced May 4, requires commercial antibody test developers to apply for Emergency Use Authorization (EUA) from the FDA under a tight time frame and also provides specific performance threshold recommendations for test specificity and sensitivity. The revised requirements follow a March 16 policy that allowed developers to validate their own tests and bring them to market without an agency review. More than 100 coronavirus antibody tests have since entered the market, fueling a congressional investigation into the accuracy of tests.
When the March policy was issued, FDA Commissioner Stephen M. Hahn, MD, said it was critical for the FDA to provide regulatory flexibility for serology test developers, given the nature of the COVID-19 public health emergency and an understanding that the tests were not meant to be used as the sole basis for COVID-19 diagnosis.
“As FDA has authorized more antibody tests and validation data has become available, including through the capability at [the National Cancer Institute] the careful balancing of risks and benefits has shifted to the approach we have outlined today and our policy update,” Dr. Hahn said during a May 4 press conference.
The new approach requires all commercial manufacturers to submit EUA requests with their validation data within 10 business days from the date they notified the FDA of their validation testing or from the date of the May 4 policy, whichever is later. Additionally, the FDA has provided specific performance threshold recommendations for specificity and sensitivity for all serology test developers.
In a statement released May 4, FDA leaders acknowledged the widespread fraud that is occurring in connection to antibody tests entering the market.
“We unfortunately see unscrupulous actors marketing fraudulent test kits and using the pandemic as an opportunity to take advantage of Americans’ anxiety,” wrote Anand Shah, MD, FDA deputy commissioner for medical and scientific affairs in a joint statement with Jeff E. Shuren, MD, director for the FDA’s Center for Devices and Radiological Health. “Some test developers have falsely claimed their serological tests are FDA approved or authorized. Others have falsely claimed that their tests can diagnose COVID-19 or that they are for at-home testing, which would fall outside of the policies outlined in our March 16 guidance, as well as the updated guidance.”
At the same time, FDA officials said they are aware of a “concerning number” of commercial serology tests that are being inappropriately marketed, including for diagnostic use, or that are performing poorly based on an independent evaluation by the National Institutes of Health, according to the May 4 statement.
In addition to tightening its requirements for test developers, the FDA also is introducing a more streamlined process to support EUA submissions and review. Two voluntary EUA templates for antibody tests are now available – one for commercial manufacturers and one for Clinical Laboratory Improvement Amendments-certified high-complexity labs seeking FDA authorization. The templates will facilitate the preparation and submission of EUA requests and can be used by any interested developer, according to the FDA.
To date, 12 antibody tests have been authorized under an individual EUA, and more than 200 antibody tests are currently the subject of a pre-EUA or EUA review, according to the FDA.
Many unknowns remain about antibody tests and how they might help researchers and clinicians understand and/or potentially treat COVID-19. Antibody tests may be able to provide information on disease prevalence and frequency of asymptomatic infection, as well as identify potential donors of “convalescent plasma,” an approach in which blood plasma containing antibodies from a recovered individual serves as a therapy for an infected patient with severe disease, Dr. Shah wrote in the May 4 statement.
“There are a lot of unanswered questions about this particular issue,” Dr. Hahn said during the press conference. “We need the data because we need to understand this particular aspect of the disease and put it as part of the puzzle around COVID-19.”
The U.S. Food and Drug Administration is tightening requirements for companies that develop COVID-19 antibody tests in an effort to combat fraud and better regulate the frenzy of tests coming to market.
The updated policy, announced May 4, requires commercial antibody test developers to apply for Emergency Use Authorization (EUA) from the FDA under a tight time frame and also provides specific performance threshold recommendations for test specificity and sensitivity. The revised requirements follow a March 16 policy that allowed developers to validate their own tests and bring them to market without an agency review. More than 100 coronavirus antibody tests have since entered the market, fueling a congressional investigation into the accuracy of tests.
When the March policy was issued, FDA Commissioner Stephen M. Hahn, MD, said it was critical for the FDA to provide regulatory flexibility for serology test developers, given the nature of the COVID-19 public health emergency and an understanding that the tests were not meant to be used as the sole basis for COVID-19 diagnosis.
“As FDA has authorized more antibody tests and validation data has become available, including through the capability at [the National Cancer Institute] the careful balancing of risks and benefits has shifted to the approach we have outlined today and our policy update,” Dr. Hahn said during a May 4 press conference.
The new approach requires all commercial manufacturers to submit EUA requests with their validation data within 10 business days from the date they notified the FDA of their validation testing or from the date of the May 4 policy, whichever is later. Additionally, the FDA has provided specific performance threshold recommendations for specificity and sensitivity for all serology test developers.
In a statement released May 4, FDA leaders acknowledged the widespread fraud that is occurring in connection to antibody tests entering the market.
“We unfortunately see unscrupulous actors marketing fraudulent test kits and using the pandemic as an opportunity to take advantage of Americans’ anxiety,” wrote Anand Shah, MD, FDA deputy commissioner for medical and scientific affairs in a joint statement with Jeff E. Shuren, MD, director for the FDA’s Center for Devices and Radiological Health. “Some test developers have falsely claimed their serological tests are FDA approved or authorized. Others have falsely claimed that their tests can diagnose COVID-19 or that they are for at-home testing, which would fall outside of the policies outlined in our March 16 guidance, as well as the updated guidance.”
At the same time, FDA officials said they are aware of a “concerning number” of commercial serology tests that are being inappropriately marketed, including for diagnostic use, or that are performing poorly based on an independent evaluation by the National Institutes of Health, according to the May 4 statement.
In addition to tightening its requirements for test developers, the FDA also is introducing a more streamlined process to support EUA submissions and review. Two voluntary EUA templates for antibody tests are now available – one for commercial manufacturers and one for Clinical Laboratory Improvement Amendments-certified high-complexity labs seeking FDA authorization. The templates will facilitate the preparation and submission of EUA requests and can be used by any interested developer, according to the FDA.
To date, 12 antibody tests have been authorized under an individual EUA, and more than 200 antibody tests are currently the subject of a pre-EUA or EUA review, according to the FDA.
Many unknowns remain about antibody tests and how they might help researchers and clinicians understand and/or potentially treat COVID-19. Antibody tests may be able to provide information on disease prevalence and frequency of asymptomatic infection, as well as identify potential donors of “convalescent plasma,” an approach in which blood plasma containing antibodies from a recovered individual serves as a therapy for an infected patient with severe disease, Dr. Shah wrote in the May 4 statement.
“There are a lot of unanswered questions about this particular issue,” Dr. Hahn said during the press conference. “We need the data because we need to understand this particular aspect of the disease and put it as part of the puzzle around COVID-19.”
The U.S. Food and Drug Administration is tightening requirements for companies that develop COVID-19 antibody tests in an effort to combat fraud and better regulate the frenzy of tests coming to market.
The updated policy, announced May 4, requires commercial antibody test developers to apply for Emergency Use Authorization (EUA) from the FDA under a tight time frame and also provides specific performance threshold recommendations for test specificity and sensitivity. The revised requirements follow a March 16 policy that allowed developers to validate their own tests and bring them to market without an agency review. More than 100 coronavirus antibody tests have since entered the market, fueling a congressional investigation into the accuracy of tests.
When the March policy was issued, FDA Commissioner Stephen M. Hahn, MD, said it was critical for the FDA to provide regulatory flexibility for serology test developers, given the nature of the COVID-19 public health emergency and an understanding that the tests were not meant to be used as the sole basis for COVID-19 diagnosis.
“As FDA has authorized more antibody tests and validation data has become available, including through the capability at [the National Cancer Institute] the careful balancing of risks and benefits has shifted to the approach we have outlined today and our policy update,” Dr. Hahn said during a May 4 press conference.
The new approach requires all commercial manufacturers to submit EUA requests with their validation data within 10 business days from the date they notified the FDA of their validation testing or from the date of the May 4 policy, whichever is later. Additionally, the FDA has provided specific performance threshold recommendations for specificity and sensitivity for all serology test developers.
In a statement released May 4, FDA leaders acknowledged the widespread fraud that is occurring in connection to antibody tests entering the market.
“We unfortunately see unscrupulous actors marketing fraudulent test kits and using the pandemic as an opportunity to take advantage of Americans’ anxiety,” wrote Anand Shah, MD, FDA deputy commissioner for medical and scientific affairs in a joint statement with Jeff E. Shuren, MD, director for the FDA’s Center for Devices and Radiological Health. “Some test developers have falsely claimed their serological tests are FDA approved or authorized. Others have falsely claimed that their tests can diagnose COVID-19 or that they are for at-home testing, which would fall outside of the policies outlined in our March 16 guidance, as well as the updated guidance.”
At the same time, FDA officials said they are aware of a “concerning number” of commercial serology tests that are being inappropriately marketed, including for diagnostic use, or that are performing poorly based on an independent evaluation by the National Institutes of Health, according to the May 4 statement.
In addition to tightening its requirements for test developers, the FDA also is introducing a more streamlined process to support EUA submissions and review. Two voluntary EUA templates for antibody tests are now available – one for commercial manufacturers and one for Clinical Laboratory Improvement Amendments-certified high-complexity labs seeking FDA authorization. The templates will facilitate the preparation and submission of EUA requests and can be used by any interested developer, according to the FDA.
To date, 12 antibody tests have been authorized under an individual EUA, and more than 200 antibody tests are currently the subject of a pre-EUA or EUA review, according to the FDA.
Many unknowns remain about antibody tests and how they might help researchers and clinicians understand and/or potentially treat COVID-19. Antibody tests may be able to provide information on disease prevalence and frequency of asymptomatic infection, as well as identify potential donors of “convalescent plasma,” an approach in which blood plasma containing antibodies from a recovered individual serves as a therapy for an infected patient with severe disease, Dr. Shah wrote in the May 4 statement.
“There are a lot of unanswered questions about this particular issue,” Dr. Hahn said during the press conference. “We need the data because we need to understand this particular aspect of the disease and put it as part of the puzzle around COVID-19.”
Progress report: Elimination of neonatal tetanus
Worldwide cases of neonatal tetanus fell by 90% from 2000 to 2018, deaths dropped by 85%, and 45 countries achieved elimination of maternal and neonatal tetanus (MNT), according to the Centers for Disease Control and Prevention.
“Despite this progress, some countries that achieved elimination are still struggling to sustain performance indicators; war and insecurity pose challenges in countries that have not achieved MNT elimination,” Henry N. Njuguna, MD, of the CDC’s global immunization division, and associates wrote in the Morbidity and Mortality Weekly Report.
Other worldwide measures also improved from 2000 to 2018: and the percentage of deliveries attended by a skilled birth attendant increased from 62% during 2000-2005 to 81% in 2013-2018, they reported.
The MNT elimination initiative, which began in 1999 and targeted 59 priority countries, immunized approximately 154 million women of reproductive age with at least two doses of tetanus toxoid–containing vaccine from 2000 to 2018, the investigators wrote, based on data from the World Health Organization and the United Nations Children’s Fund.
With 14 of the priority countries – including Nigeria, Pakistan, and Yemen – still dealing with MNT, however, numerous challenges remain, they noted. About 47 million women and their babies are still unprotected, and 49 million women have not received tetanus toxoid–containing vaccine.
This lack of coverage “can be attributed to weak health systems, including conflict and security issues that limit access to vaccination services, competing priorities that limit the implementation of planned MNT elimination activities, and withdrawal of donor funding,” Dr. Njuguna and associates wrote.
SOURCE: Njuguna HN et al. MMWR. 2020 May 1;69(17):515-20.
Worldwide cases of neonatal tetanus fell by 90% from 2000 to 2018, deaths dropped by 85%, and 45 countries achieved elimination of maternal and neonatal tetanus (MNT), according to the Centers for Disease Control and Prevention.
“Despite this progress, some countries that achieved elimination are still struggling to sustain performance indicators; war and insecurity pose challenges in countries that have not achieved MNT elimination,” Henry N. Njuguna, MD, of the CDC’s global immunization division, and associates wrote in the Morbidity and Mortality Weekly Report.
Other worldwide measures also improved from 2000 to 2018: and the percentage of deliveries attended by a skilled birth attendant increased from 62% during 2000-2005 to 81% in 2013-2018, they reported.
The MNT elimination initiative, which began in 1999 and targeted 59 priority countries, immunized approximately 154 million women of reproductive age with at least two doses of tetanus toxoid–containing vaccine from 2000 to 2018, the investigators wrote, based on data from the World Health Organization and the United Nations Children’s Fund.
With 14 of the priority countries – including Nigeria, Pakistan, and Yemen – still dealing with MNT, however, numerous challenges remain, they noted. About 47 million women and their babies are still unprotected, and 49 million women have not received tetanus toxoid–containing vaccine.
This lack of coverage “can be attributed to weak health systems, including conflict and security issues that limit access to vaccination services, competing priorities that limit the implementation of planned MNT elimination activities, and withdrawal of donor funding,” Dr. Njuguna and associates wrote.
SOURCE: Njuguna HN et al. MMWR. 2020 May 1;69(17):515-20.
Worldwide cases of neonatal tetanus fell by 90% from 2000 to 2018, deaths dropped by 85%, and 45 countries achieved elimination of maternal and neonatal tetanus (MNT), according to the Centers for Disease Control and Prevention.
“Despite this progress, some countries that achieved elimination are still struggling to sustain performance indicators; war and insecurity pose challenges in countries that have not achieved MNT elimination,” Henry N. Njuguna, MD, of the CDC’s global immunization division, and associates wrote in the Morbidity and Mortality Weekly Report.
Other worldwide measures also improved from 2000 to 2018: and the percentage of deliveries attended by a skilled birth attendant increased from 62% during 2000-2005 to 81% in 2013-2018, they reported.
The MNT elimination initiative, which began in 1999 and targeted 59 priority countries, immunized approximately 154 million women of reproductive age with at least two doses of tetanus toxoid–containing vaccine from 2000 to 2018, the investigators wrote, based on data from the World Health Organization and the United Nations Children’s Fund.
With 14 of the priority countries – including Nigeria, Pakistan, and Yemen – still dealing with MNT, however, numerous challenges remain, they noted. About 47 million women and their babies are still unprotected, and 49 million women have not received tetanus toxoid–containing vaccine.
This lack of coverage “can be attributed to weak health systems, including conflict and security issues that limit access to vaccination services, competing priorities that limit the implementation of planned MNT elimination activities, and withdrawal of donor funding,” Dr. Njuguna and associates wrote.
SOURCE: Njuguna HN et al. MMWR. 2020 May 1;69(17):515-20.
FROM MMWR
FDA grants Breakthrough Therapy status to sotatercept for PAH treatment
Approval for sotatercept, “a selective ligand trap for members of the TGF-beta [transforming growth factor-beta] superfamily which rebalances BMPR-II [bone morphogenetic protein receptor type II] signaling,” was based on two types of research. It was based on results of preclinical research indicating “reversed pulmonary vessel muscularization and improved indicators of right heart failure,” as well as results of the phase 2, placebo-controlled PULSAR study, in which sotatercept showed positive results, meeting primary and secondary endpoints.
Adverse events during PULSAR “were consistent with previously published data on sotatercept” in other diseases. The drug is also under investigation in the phase 2 SPECTRA trial, which includes patients with PAH.
“We believe that sotatercept has the potential to shift the current treatment paradigm and provide significant benefit to patients with PAH on top of currently available therapies. Thus, we’re thrilled that the FDA has granted this Breakthrough Therapy designation – a first for an Acceleron-discovered medicine and for a therapeutic candidate in PAH – as it supports and aligns with our mission to deliver novel therapeutic options to patients in need as quickly as possible,” Habib Dable, president and CEO of Acceleron Pharma, said in the press release.
Approval for sotatercept, “a selective ligand trap for members of the TGF-beta [transforming growth factor-beta] superfamily which rebalances BMPR-II [bone morphogenetic protein receptor type II] signaling,” was based on two types of research. It was based on results of preclinical research indicating “reversed pulmonary vessel muscularization and improved indicators of right heart failure,” as well as results of the phase 2, placebo-controlled PULSAR study, in which sotatercept showed positive results, meeting primary and secondary endpoints.
Adverse events during PULSAR “were consistent with previously published data on sotatercept” in other diseases. The drug is also under investigation in the phase 2 SPECTRA trial, which includes patients with PAH.
“We believe that sotatercept has the potential to shift the current treatment paradigm and provide significant benefit to patients with PAH on top of currently available therapies. Thus, we’re thrilled that the FDA has granted this Breakthrough Therapy designation – a first for an Acceleron-discovered medicine and for a therapeutic candidate in PAH – as it supports and aligns with our mission to deliver novel therapeutic options to patients in need as quickly as possible,” Habib Dable, president and CEO of Acceleron Pharma, said in the press release.
Approval for sotatercept, “a selective ligand trap for members of the TGF-beta [transforming growth factor-beta] superfamily which rebalances BMPR-II [bone morphogenetic protein receptor type II] signaling,” was based on two types of research. It was based on results of preclinical research indicating “reversed pulmonary vessel muscularization and improved indicators of right heart failure,” as well as results of the phase 2, placebo-controlled PULSAR study, in which sotatercept showed positive results, meeting primary and secondary endpoints.
Adverse events during PULSAR “were consistent with previously published data on sotatercept” in other diseases. The drug is also under investigation in the phase 2 SPECTRA trial, which includes patients with PAH.
“We believe that sotatercept has the potential to shift the current treatment paradigm and provide significant benefit to patients with PAH on top of currently available therapies. Thus, we’re thrilled that the FDA has granted this Breakthrough Therapy designation – a first for an Acceleron-discovered medicine and for a therapeutic candidate in PAH – as it supports and aligns with our mission to deliver novel therapeutic options to patients in need as quickly as possible,” Habib Dable, president and CEO of Acceleron Pharma, said in the press release.
FDA OKs new drug for triple-negative breast cancer
The US Food and Drug Administration (FDA) granted accelerated approval to sacituzumab govitecan (Trodelvy, Immunomedics) for the treatment of metastatic triple-negative breast cancer (TNBC).
Eligible patients must have received at least two prior therapies.
TNBC is so-called because it lacks the three cellular targets present in more common forms of breast cancer. It is usually treated with chemotherapy.
Sacituzumab govitecan offers a new approach – and it has a target.
Given intravenously, the new drug is an antibody-drug conjugate in which SN-38, an active metabolite of the chemotherapy drug irinotecan (multiple brands), is coupled to a monoclonal antibody that targets an antigen that has high expression in TNBC and induces cancer cell growth.
“Metastatic triple-negative breast cancer is an aggressive form of breast cancer with limited treatment options,” observed Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research in a press statement. “There is intense interest in finding new medications” for this patient population, he added.
The new approval is based on safety and efficacy results from a phase 1/2 clinical trial of 108 patients (median age, 56 years) who had received at least two prior treatments for metastatic disease.
The overall response rate was 33% (n = 36), including three complete responses. Median duration of response was 7.7 months. Of responders, 55.6% maintained their response for at least 6 months and 16.7% for at least 12 months.
Median progression-free survival was 5.5 months, and median overall survival was 13.0 months.
The study data were published last year in the New England Journal of Medicine.
“It’s not every day that we see this sort of clinical activity in this aggressive subtype of breast cancer,” said senior study author Kevin Kalinsky, MD, in an interview at that time. He is a medical oncologist at New York–Presbyterian Hospital and Columbia University Medical Center in New York City.
The most common side effects of the new therapy were nausea, neutropenia, diarrhea, fatigue, anemia, vomiting, alopecia, constipation, decreased appetite, rash, and abdominal pain.
No peripheral neuropathy of grade 3 or higher was reported.
In the study, patients received sacituzumab govitecan intravenously (10 mg/kg body weight) on days 1 and 8 of each 21-day cycle until disease progression or unacceptable toxicity.
The 108 participants received a mean 18.7 doses of sacituzumab govitecan, or 9.6 cycles. The median duration of exposure was 5.1 months.
Three patients discontinued treatment because of adverse events, and two patients discontinued because of drug-related events.
The prescribing information includes a boxed warning regarding the risks of severe neutropenia and severe diarrhea. Blood cell counts should be monitored during treatment and granulocyte-colony stimulating factor (G-CSF) therapy should be considered. Anti-infective treatment should be initiated in the event of febrile neutropenia. Patients with reduced uridine diphosphate-glucuronosyltransferase 1A1 (UGT1A1) activity are at increased risk for neutropenia following initiation of treatment.
The new drug can also cause hypersensitivity reactions including severe anaphylactic reactions.
Women who are pregnant should not take sacituzumab govitecan.
This article first appeared on Medscape.com.
The US Food and Drug Administration (FDA) granted accelerated approval to sacituzumab govitecan (Trodelvy, Immunomedics) for the treatment of metastatic triple-negative breast cancer (TNBC).
Eligible patients must have received at least two prior therapies.
TNBC is so-called because it lacks the three cellular targets present in more common forms of breast cancer. It is usually treated with chemotherapy.
Sacituzumab govitecan offers a new approach – and it has a target.
Given intravenously, the new drug is an antibody-drug conjugate in which SN-38, an active metabolite of the chemotherapy drug irinotecan (multiple brands), is coupled to a monoclonal antibody that targets an antigen that has high expression in TNBC and induces cancer cell growth.
“Metastatic triple-negative breast cancer is an aggressive form of breast cancer with limited treatment options,” observed Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research in a press statement. “There is intense interest in finding new medications” for this patient population, he added.
The new approval is based on safety and efficacy results from a phase 1/2 clinical trial of 108 patients (median age, 56 years) who had received at least two prior treatments for metastatic disease.
The overall response rate was 33% (n = 36), including three complete responses. Median duration of response was 7.7 months. Of responders, 55.6% maintained their response for at least 6 months and 16.7% for at least 12 months.
Median progression-free survival was 5.5 months, and median overall survival was 13.0 months.
The study data were published last year in the New England Journal of Medicine.
“It’s not every day that we see this sort of clinical activity in this aggressive subtype of breast cancer,” said senior study author Kevin Kalinsky, MD, in an interview at that time. He is a medical oncologist at New York–Presbyterian Hospital and Columbia University Medical Center in New York City.
The most common side effects of the new therapy were nausea, neutropenia, diarrhea, fatigue, anemia, vomiting, alopecia, constipation, decreased appetite, rash, and abdominal pain.
No peripheral neuropathy of grade 3 or higher was reported.
In the study, patients received sacituzumab govitecan intravenously (10 mg/kg body weight) on days 1 and 8 of each 21-day cycle until disease progression or unacceptable toxicity.
The 108 participants received a mean 18.7 doses of sacituzumab govitecan, or 9.6 cycles. The median duration of exposure was 5.1 months.
Three patients discontinued treatment because of adverse events, and two patients discontinued because of drug-related events.
The prescribing information includes a boxed warning regarding the risks of severe neutropenia and severe diarrhea. Blood cell counts should be monitored during treatment and granulocyte-colony stimulating factor (G-CSF) therapy should be considered. Anti-infective treatment should be initiated in the event of febrile neutropenia. Patients with reduced uridine diphosphate-glucuronosyltransferase 1A1 (UGT1A1) activity are at increased risk for neutropenia following initiation of treatment.
The new drug can also cause hypersensitivity reactions including severe anaphylactic reactions.
Women who are pregnant should not take sacituzumab govitecan.
This article first appeared on Medscape.com.
The US Food and Drug Administration (FDA) granted accelerated approval to sacituzumab govitecan (Trodelvy, Immunomedics) for the treatment of metastatic triple-negative breast cancer (TNBC).
Eligible patients must have received at least two prior therapies.
TNBC is so-called because it lacks the three cellular targets present in more common forms of breast cancer. It is usually treated with chemotherapy.
Sacituzumab govitecan offers a new approach – and it has a target.
Given intravenously, the new drug is an antibody-drug conjugate in which SN-38, an active metabolite of the chemotherapy drug irinotecan (multiple brands), is coupled to a monoclonal antibody that targets an antigen that has high expression in TNBC and induces cancer cell growth.
“Metastatic triple-negative breast cancer is an aggressive form of breast cancer with limited treatment options,” observed Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research in a press statement. “There is intense interest in finding new medications” for this patient population, he added.
The new approval is based on safety and efficacy results from a phase 1/2 clinical trial of 108 patients (median age, 56 years) who had received at least two prior treatments for metastatic disease.
The overall response rate was 33% (n = 36), including three complete responses. Median duration of response was 7.7 months. Of responders, 55.6% maintained their response for at least 6 months and 16.7% for at least 12 months.
Median progression-free survival was 5.5 months, and median overall survival was 13.0 months.
The study data were published last year in the New England Journal of Medicine.
“It’s not every day that we see this sort of clinical activity in this aggressive subtype of breast cancer,” said senior study author Kevin Kalinsky, MD, in an interview at that time. He is a medical oncologist at New York–Presbyterian Hospital and Columbia University Medical Center in New York City.
The most common side effects of the new therapy were nausea, neutropenia, diarrhea, fatigue, anemia, vomiting, alopecia, constipation, decreased appetite, rash, and abdominal pain.
No peripheral neuropathy of grade 3 or higher was reported.
In the study, patients received sacituzumab govitecan intravenously (10 mg/kg body weight) on days 1 and 8 of each 21-day cycle until disease progression or unacceptable toxicity.
The 108 participants received a mean 18.7 doses of sacituzumab govitecan, or 9.6 cycles. The median duration of exposure was 5.1 months.
Three patients discontinued treatment because of adverse events, and two patients discontinued because of drug-related events.
The prescribing information includes a boxed warning regarding the risks of severe neutropenia and severe diarrhea. Blood cell counts should be monitored during treatment and granulocyte-colony stimulating factor (G-CSF) therapy should be considered. Anti-infective treatment should be initiated in the event of febrile neutropenia. Patients with reduced uridine diphosphate-glucuronosyltransferase 1A1 (UGT1A1) activity are at increased risk for neutropenia following initiation of treatment.
The new drug can also cause hypersensitivity reactions including severe anaphylactic reactions.
Women who are pregnant should not take sacituzumab govitecan.
This article first appeared on Medscape.com.
FDA approves ibrutinib-rituximab combo for newly diagnosed CLL, SLL in adults
The Food and Drug Administration has expanded the indication for ibrutinib (Imbruvica) to allow its combination with rituximab for frontline treatment of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) in adults.
The approval, announced April 21, was based on findings from the randomized, controlled, open-label, phase 3 E1912 trial of 529 patients, which demonstrated significantly improved progression-free survival (PFS) among those who received ibrutinib plus rituximab, compared with those who received fludarabine, cyclophosphamide, and rituximab (FCR) (87% vs. 75%; hazard ratio, 0.34). Median PFS was not reached in either arm after a median follow-up of 37 months.
E1912 was the first study to show superiority of a chemotherapy-free regimen over FCR chemoimmunotherapy, considered the gold standard for newly diagnosed CLL and SLL for the past 2 decades.
The recommended dosage for the newly approved combination is a once-daily 420-mg dose of ibrutinib taken with a glass of water, with rituximab initiation in the second cycle at doses of 50 mg/m2 on day 1, 325 mg/m2 on day 2, and 500 mg/m2 on days 1-5 of subsequent cycles for a total of six cycles.
The Food and Drug Administration has expanded the indication for ibrutinib (Imbruvica) to allow its combination with rituximab for frontline treatment of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) in adults.
The approval, announced April 21, was based on findings from the randomized, controlled, open-label, phase 3 E1912 trial of 529 patients, which demonstrated significantly improved progression-free survival (PFS) among those who received ibrutinib plus rituximab, compared with those who received fludarabine, cyclophosphamide, and rituximab (FCR) (87% vs. 75%; hazard ratio, 0.34). Median PFS was not reached in either arm after a median follow-up of 37 months.
E1912 was the first study to show superiority of a chemotherapy-free regimen over FCR chemoimmunotherapy, considered the gold standard for newly diagnosed CLL and SLL for the past 2 decades.
The recommended dosage for the newly approved combination is a once-daily 420-mg dose of ibrutinib taken with a glass of water, with rituximab initiation in the second cycle at doses of 50 mg/m2 on day 1, 325 mg/m2 on day 2, and 500 mg/m2 on days 1-5 of subsequent cycles for a total of six cycles.
The Food and Drug Administration has expanded the indication for ibrutinib (Imbruvica) to allow its combination with rituximab for frontline treatment of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) in adults.
The approval, announced April 21, was based on findings from the randomized, controlled, open-label, phase 3 E1912 trial of 529 patients, which demonstrated significantly improved progression-free survival (PFS) among those who received ibrutinib plus rituximab, compared with those who received fludarabine, cyclophosphamide, and rituximab (FCR) (87% vs. 75%; hazard ratio, 0.34). Median PFS was not reached in either arm after a median follow-up of 37 months.
E1912 was the first study to show superiority of a chemotherapy-free regimen over FCR chemoimmunotherapy, considered the gold standard for newly diagnosed CLL and SLL for the past 2 decades.
The recommended dosage for the newly approved combination is a once-daily 420-mg dose of ibrutinib taken with a glass of water, with rituximab initiation in the second cycle at doses of 50 mg/m2 on day 1, 325 mg/m2 on day 2, and 500 mg/m2 on days 1-5 of subsequent cycles for a total of six cycles.
FDA authorizes first COVID-19 test kit with home collection option
a reissue of the emergency use authorization allowing for testing of samples self-collected by patients at home with the Pixel by LabCorp COVID-19 RT-PCR Test.
The reissued authorization allows for testing of a sample taken from the nose by way of a self-collection kit that contains nasal swabs and saline, according to the FDA press release. After self-swabbing, users should send the samples in an insulated package to a LabCorp laboratory for testing. LabCorp intends to make the Pixel test available to consumers in most states, accessible through doctors’ orders.
The Pixel test includes a specific Q-tip–style cotton swab for patients to use to collect their samples, the FDA noted. Because of concerns with sterility and cross-reactivity caused by inherent genetic material in cotton swabs, generic cotton swabs should not be used as a substitute. The FDA will work with test developers to determine if generic cotton swabs can be used safely and effectively with other tests.
“Throughout this pandemic we have been facilitating test development to ensure patients’ access to accurate diagnostics, which includes supporting the development of reliable and accurate at-home sample collection options. ... [The FDA] worked with LabCorp to ensure the data demonstrated from at-home patient sample collection is as safe and accurate as sample collection at a doctor’s office, hospital, or other testing site. With this action, there is now a convenient and reliable option for patient sample collection from the comfort and safety of their home,” FDA Commissioner Stephen M. Hahn, MD, said in the press release.
a reissue of the emergency use authorization allowing for testing of samples self-collected by patients at home with the Pixel by LabCorp COVID-19 RT-PCR Test.
The reissued authorization allows for testing of a sample taken from the nose by way of a self-collection kit that contains nasal swabs and saline, according to the FDA press release. After self-swabbing, users should send the samples in an insulated package to a LabCorp laboratory for testing. LabCorp intends to make the Pixel test available to consumers in most states, accessible through doctors’ orders.
The Pixel test includes a specific Q-tip–style cotton swab for patients to use to collect their samples, the FDA noted. Because of concerns with sterility and cross-reactivity caused by inherent genetic material in cotton swabs, generic cotton swabs should not be used as a substitute. The FDA will work with test developers to determine if generic cotton swabs can be used safely and effectively with other tests.
“Throughout this pandemic we have been facilitating test development to ensure patients’ access to accurate diagnostics, which includes supporting the development of reliable and accurate at-home sample collection options. ... [The FDA] worked with LabCorp to ensure the data demonstrated from at-home patient sample collection is as safe and accurate as sample collection at a doctor’s office, hospital, or other testing site. With this action, there is now a convenient and reliable option for patient sample collection from the comfort and safety of their home,” FDA Commissioner Stephen M. Hahn, MD, said in the press release.
a reissue of the emergency use authorization allowing for testing of samples self-collected by patients at home with the Pixel by LabCorp COVID-19 RT-PCR Test.
The reissued authorization allows for testing of a sample taken from the nose by way of a self-collection kit that contains nasal swabs and saline, according to the FDA press release. After self-swabbing, users should send the samples in an insulated package to a LabCorp laboratory for testing. LabCorp intends to make the Pixel test available to consumers in most states, accessible through doctors’ orders.
The Pixel test includes a specific Q-tip–style cotton swab for patients to use to collect their samples, the FDA noted. Because of concerns with sterility and cross-reactivity caused by inherent genetic material in cotton swabs, generic cotton swabs should not be used as a substitute. The FDA will work with test developers to determine if generic cotton swabs can be used safely and effectively with other tests.
“Throughout this pandemic we have been facilitating test development to ensure patients’ access to accurate diagnostics, which includes supporting the development of reliable and accurate at-home sample collection options. ... [The FDA] worked with LabCorp to ensure the data demonstrated from at-home patient sample collection is as safe and accurate as sample collection at a doctor’s office, hospital, or other testing site. With this action, there is now a convenient and reliable option for patient sample collection from the comfort and safety of their home,” FDA Commissioner Stephen M. Hahn, MD, said in the press release.