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FDA addresses cell-based regenerative medicine in comprehensive new policy
The Food and Drug Administration has announced a new policy that addresses the rapid growth and development of regenerative medicine products, which include novel cellular therapies, with the aim of ensuring their safety and effectiveness.
“The framework – outlined in a suite of four guidance documents – builds upon the FDA’s existing risk-based regulatory approach to more clearly describe what products are regulated as drugs, devices, and/or biological products,” the FDA announced in a statement released on Nov. 16.
He added: “This is no longer the stuff of science fiction. This is the practical promise of modern applications of regenerative medicine.” But, while advances have benefited many patients, he referred to a small number of “unscrupulous actors” that have provided treatments that have harmed patients, which is why stricter FDA enforcement is needed.
Clarification of the existing regulations will “promote responsible and flexible regulation that leverages science to advance public health,” Dr. Gottlieb said during a media briefing held by the FDA to discuss the new framework.
During the briefing, in response to a question concerning adipose tissue injections and their associated risks, Peter Marks, MD, director of the FDA’s Center for Biologics Evaluation and Research, explained that the guidance documents will clearly delineate when adipose tissue will be classified as a structural tissue and a stem cell product. If a provider is purveying dangerous products, the FDA can “when necessary, undertake seizures, ask for injunctions, and in some cases when it has been determined that certain violations have occurred even criminal actions can be taken,” he said.
Earlier this year, a report of three patients who had severe visual loss after treatment with intravitreal injections of autologous adipose tissue for age-related macular degeneration was published (N Engl J Med. 2017;376:1047-53).
The new framework is composed of two final guidance documents and two draft guidance documents. The first final guidance document provides details about regulations concerning cell and tissue-based products and when those products are subject to regulation in surgical procedures. The second final guidance document elaborates on the definition of “minimal manipulation” and “homologous use” with the hopes of clarifying what products are subject to regulation. These documents will also explain how the FDA will provide a framework for premarket authorization for cell-based regenerative products.
One draft guidance outlines the FDA’s plan to simplify and expedite the application of the regulatory requirements for devices used in relation to regenerative medicine advanced therapies; the second draft guidance outlines the expedited programs that may be available to sponsors of regenerative therapies.
The Food and Drug Administration has announced a new policy that addresses the rapid growth and development of regenerative medicine products, which include novel cellular therapies, with the aim of ensuring their safety and effectiveness.
“The framework – outlined in a suite of four guidance documents – builds upon the FDA’s existing risk-based regulatory approach to more clearly describe what products are regulated as drugs, devices, and/or biological products,” the FDA announced in a statement released on Nov. 16.
He added: “This is no longer the stuff of science fiction. This is the practical promise of modern applications of regenerative medicine.” But, while advances have benefited many patients, he referred to a small number of “unscrupulous actors” that have provided treatments that have harmed patients, which is why stricter FDA enforcement is needed.
Clarification of the existing regulations will “promote responsible and flexible regulation that leverages science to advance public health,” Dr. Gottlieb said during a media briefing held by the FDA to discuss the new framework.
During the briefing, in response to a question concerning adipose tissue injections and their associated risks, Peter Marks, MD, director of the FDA’s Center for Biologics Evaluation and Research, explained that the guidance documents will clearly delineate when adipose tissue will be classified as a structural tissue and a stem cell product. If a provider is purveying dangerous products, the FDA can “when necessary, undertake seizures, ask for injunctions, and in some cases when it has been determined that certain violations have occurred even criminal actions can be taken,” he said.
Earlier this year, a report of three patients who had severe visual loss after treatment with intravitreal injections of autologous adipose tissue for age-related macular degeneration was published (N Engl J Med. 2017;376:1047-53).
The new framework is composed of two final guidance documents and two draft guidance documents. The first final guidance document provides details about regulations concerning cell and tissue-based products and when those products are subject to regulation in surgical procedures. The second final guidance document elaborates on the definition of “minimal manipulation” and “homologous use” with the hopes of clarifying what products are subject to regulation. These documents will also explain how the FDA will provide a framework for premarket authorization for cell-based regenerative products.
One draft guidance outlines the FDA’s plan to simplify and expedite the application of the regulatory requirements for devices used in relation to regenerative medicine advanced therapies; the second draft guidance outlines the expedited programs that may be available to sponsors of regenerative therapies.
The Food and Drug Administration has announced a new policy that addresses the rapid growth and development of regenerative medicine products, which include novel cellular therapies, with the aim of ensuring their safety and effectiveness.
“The framework – outlined in a suite of four guidance documents – builds upon the FDA’s existing risk-based regulatory approach to more clearly describe what products are regulated as drugs, devices, and/or biological products,” the FDA announced in a statement released on Nov. 16.
He added: “This is no longer the stuff of science fiction. This is the practical promise of modern applications of regenerative medicine.” But, while advances have benefited many patients, he referred to a small number of “unscrupulous actors” that have provided treatments that have harmed patients, which is why stricter FDA enforcement is needed.
Clarification of the existing regulations will “promote responsible and flexible regulation that leverages science to advance public health,” Dr. Gottlieb said during a media briefing held by the FDA to discuss the new framework.
During the briefing, in response to a question concerning adipose tissue injections and their associated risks, Peter Marks, MD, director of the FDA’s Center for Biologics Evaluation and Research, explained that the guidance documents will clearly delineate when adipose tissue will be classified as a structural tissue and a stem cell product. If a provider is purveying dangerous products, the FDA can “when necessary, undertake seizures, ask for injunctions, and in some cases when it has been determined that certain violations have occurred even criminal actions can be taken,” he said.
Earlier this year, a report of three patients who had severe visual loss after treatment with intravitreal injections of autologous adipose tissue for age-related macular degeneration was published (N Engl J Med. 2017;376:1047-53).
The new framework is composed of two final guidance documents and two draft guidance documents. The first final guidance document provides details about regulations concerning cell and tissue-based products and when those products are subject to regulation in surgical procedures. The second final guidance document elaborates on the definition of “minimal manipulation” and “homologous use” with the hopes of clarifying what products are subject to regulation. These documents will also explain how the FDA will provide a framework for premarket authorization for cell-based regenerative products.
One draft guidance outlines the FDA’s plan to simplify and expedite the application of the regulatory requirements for devices used in relation to regenerative medicine advanced therapies; the second draft guidance outlines the expedited programs that may be available to sponsors of regenerative therapies.
FROM an FDA MEDIA BRIEFING
FDA issues alert on illegal silicone injections
The Food and Drug Administration has issued a warning regarding the use of injectable silicone or other products illegally marketed as dermal fillers for body contouring.
“We have significant concerns with unsafe injectable silicone that’s being marketed for body contouring by unlicensed providers,” FDA Commissioner Scott Gottlieb, MD, said in a statement on Nov. 14. “We’ve seen serious adverse events result from products, which are sometimes industrial-grade silicone, being used for these unapproved medical purposes,” he said.
Simply injecting silicone into various parts of the body for contouring purposes is not approved by the FDA. Side effects of such a procedure can occur immediately, or may appear after days, weeks, months, or years, according to the statement. Side effects include pain, scarring, disfigurement, life-threatening embolism, stroke, or infection, the FDA emphasized.
The FDA continues to take action against unlicensed practitioners found guilty of treating patients with unapproved silicone for body contouring. “In addition to prosecuting the criminals who take advantage of consumers, the FDA is taking action to educate consumers in order to prevent the serious injuries resulting from these injections,” Melinda Plaisier, associate commissioner for regulatory affairs at the FDA, said in the statement. “We hope to raise public awareness about the short- and long-term risks of injecting silicone directly into the body, and encourage consumers to choose FDA-approved products and licensed providers when considering any type of cosmetic enhancement,” she said.
The FDA will continue to monitor adverse event reports related to silicone, and encourages clinicians or consumers with information about the use of injectable silicone by unlicensed providers to use the “Report Suspected Criminal Activity” form on the FDA website to report those cases.
The Food and Drug Administration has issued a warning regarding the use of injectable silicone or other products illegally marketed as dermal fillers for body contouring.
“We have significant concerns with unsafe injectable silicone that’s being marketed for body contouring by unlicensed providers,” FDA Commissioner Scott Gottlieb, MD, said in a statement on Nov. 14. “We’ve seen serious adverse events result from products, which are sometimes industrial-grade silicone, being used for these unapproved medical purposes,” he said.
Simply injecting silicone into various parts of the body for contouring purposes is not approved by the FDA. Side effects of such a procedure can occur immediately, or may appear after days, weeks, months, or years, according to the statement. Side effects include pain, scarring, disfigurement, life-threatening embolism, stroke, or infection, the FDA emphasized.
The FDA continues to take action against unlicensed practitioners found guilty of treating patients with unapproved silicone for body contouring. “In addition to prosecuting the criminals who take advantage of consumers, the FDA is taking action to educate consumers in order to prevent the serious injuries resulting from these injections,” Melinda Plaisier, associate commissioner for regulatory affairs at the FDA, said in the statement. “We hope to raise public awareness about the short- and long-term risks of injecting silicone directly into the body, and encourage consumers to choose FDA-approved products and licensed providers when considering any type of cosmetic enhancement,” she said.
The FDA will continue to monitor adverse event reports related to silicone, and encourages clinicians or consumers with information about the use of injectable silicone by unlicensed providers to use the “Report Suspected Criminal Activity” form on the FDA website to report those cases.
The Food and Drug Administration has issued a warning regarding the use of injectable silicone or other products illegally marketed as dermal fillers for body contouring.
“We have significant concerns with unsafe injectable silicone that’s being marketed for body contouring by unlicensed providers,” FDA Commissioner Scott Gottlieb, MD, said in a statement on Nov. 14. “We’ve seen serious adverse events result from products, which are sometimes industrial-grade silicone, being used for these unapproved medical purposes,” he said.
Simply injecting silicone into various parts of the body for contouring purposes is not approved by the FDA. Side effects of such a procedure can occur immediately, or may appear after days, weeks, months, or years, according to the statement. Side effects include pain, scarring, disfigurement, life-threatening embolism, stroke, or infection, the FDA emphasized.
The FDA continues to take action against unlicensed practitioners found guilty of treating patients with unapproved silicone for body contouring. “In addition to prosecuting the criminals who take advantage of consumers, the FDA is taking action to educate consumers in order to prevent the serious injuries resulting from these injections,” Melinda Plaisier, associate commissioner for regulatory affairs at the FDA, said in the statement. “We hope to raise public awareness about the short- and long-term risks of injecting silicone directly into the body, and encourage consumers to choose FDA-approved products and licensed providers when considering any type of cosmetic enhancement,” she said.
The FDA will continue to monitor adverse event reports related to silicone, and encourages clinicians or consumers with information about the use of injectable silicone by unlicensed providers to use the “Report Suspected Criminal Activity” form on the FDA website to report those cases.
FDA clears first-ever neurostimulation device for opioid withdrawal symptoms
The Food and Drug Administration has cleared a medical device that applies electrical stimulation to cranial nerves in order to reduce opioid withdrawal symptoms.
The clearance was granted amid the opioid crisis, which is killing 175 Americans each day, according to the recent report by The President’s Commission on Combating Drug Addiction and the Opioid Crisis. Currently, opioid addiction is treatable by three approved medications, said FDA Commissioner Scott Gottlieb, MD, in a press statement announcing the agency’s decision to permit marketing of the NSS-2 Bridge device.
“While we continue to pursue better medicines for the treatment of opioid use disorder, we also need to look to devices that can assist in this therapy,” Dr. Gottlieb said.
The NSS-2 Bridge device was cleared as an acupuncture aid in 2014. The new use of the device to reduce the symptoms of opioid withdrawal required a new clearance, which was granted based on a single, one-arm clinical study. In the study, 73 patients who were experiencing physical withdrawal from opioids used the neurostimulation device. They reported an initial mean score of 20.1 on the Clinical Opiate Withdrawal Score (COWS). All patients using the device had a reduction of at least 31% on the COWS within 30 minutes of beginning use of the NSS-2 Bridge. A total of 88% of participating patients transitioned to medication-assisted treatment after 5 days of using the device. Additional medications used to treat specific symptoms, such as nausea and vomiting, were permitted during the trial.
The physician-placed battery-powered device sits behind the ear and uses three percutaneous electrode arrays and one single-point needle to provide neurostimulation. The electrode placement is assisted with a transillumination technique, and also is based on known neuroanatomic landmarks for branches of cranial nerves V, VII, and IX, along with branches of the occipital nerve (Clin Med Diagnostics. 2015;5[4]:70-9).
The single-use device is designed to be used for up to 5 days during acute opioid withdrawal and is contraindicated for patients with hemophilia, patients with cardiac pacemakers, or those diagnosed with psoriasis vulgaris. The NSS-2 Bridge device requires a prescription and was cleared through the de novo premarket review pathway. This, said the FDA in the press statement, is “a regulatory pathway for some low- to moderate-risk devices that are novel and for which there is no legally marketed predicate device to which the device can claim substantial equivalence.”
The NSS-2 Bridge device will be marketed by Innovative Health Solutions.
koakes@frontlinemedcom.com
On Twitter @karioakes
The Food and Drug Administration has cleared a medical device that applies electrical stimulation to cranial nerves in order to reduce opioid withdrawal symptoms.
The clearance was granted amid the opioid crisis, which is killing 175 Americans each day, according to the recent report by The President’s Commission on Combating Drug Addiction and the Opioid Crisis. Currently, opioid addiction is treatable by three approved medications, said FDA Commissioner Scott Gottlieb, MD, in a press statement announcing the agency’s decision to permit marketing of the NSS-2 Bridge device.
“While we continue to pursue better medicines for the treatment of opioid use disorder, we also need to look to devices that can assist in this therapy,” Dr. Gottlieb said.
The NSS-2 Bridge device was cleared as an acupuncture aid in 2014. The new use of the device to reduce the symptoms of opioid withdrawal required a new clearance, which was granted based on a single, one-arm clinical study. In the study, 73 patients who were experiencing physical withdrawal from opioids used the neurostimulation device. They reported an initial mean score of 20.1 on the Clinical Opiate Withdrawal Score (COWS). All patients using the device had a reduction of at least 31% on the COWS within 30 minutes of beginning use of the NSS-2 Bridge. A total of 88% of participating patients transitioned to medication-assisted treatment after 5 days of using the device. Additional medications used to treat specific symptoms, such as nausea and vomiting, were permitted during the trial.
The physician-placed battery-powered device sits behind the ear and uses three percutaneous electrode arrays and one single-point needle to provide neurostimulation. The electrode placement is assisted with a transillumination technique, and also is based on known neuroanatomic landmarks for branches of cranial nerves V, VII, and IX, along with branches of the occipital nerve (Clin Med Diagnostics. 2015;5[4]:70-9).
The single-use device is designed to be used for up to 5 days during acute opioid withdrawal and is contraindicated for patients with hemophilia, patients with cardiac pacemakers, or those diagnosed with psoriasis vulgaris. The NSS-2 Bridge device requires a prescription and was cleared through the de novo premarket review pathway. This, said the FDA in the press statement, is “a regulatory pathway for some low- to moderate-risk devices that are novel and for which there is no legally marketed predicate device to which the device can claim substantial equivalence.”
The NSS-2 Bridge device will be marketed by Innovative Health Solutions.
koakes@frontlinemedcom.com
On Twitter @karioakes
The Food and Drug Administration has cleared a medical device that applies electrical stimulation to cranial nerves in order to reduce opioid withdrawal symptoms.
The clearance was granted amid the opioid crisis, which is killing 175 Americans each day, according to the recent report by The President’s Commission on Combating Drug Addiction and the Opioid Crisis. Currently, opioid addiction is treatable by three approved medications, said FDA Commissioner Scott Gottlieb, MD, in a press statement announcing the agency’s decision to permit marketing of the NSS-2 Bridge device.
“While we continue to pursue better medicines for the treatment of opioid use disorder, we also need to look to devices that can assist in this therapy,” Dr. Gottlieb said.
The NSS-2 Bridge device was cleared as an acupuncture aid in 2014. The new use of the device to reduce the symptoms of opioid withdrawal required a new clearance, which was granted based on a single, one-arm clinical study. In the study, 73 patients who were experiencing physical withdrawal from opioids used the neurostimulation device. They reported an initial mean score of 20.1 on the Clinical Opiate Withdrawal Score (COWS). All patients using the device had a reduction of at least 31% on the COWS within 30 minutes of beginning use of the NSS-2 Bridge. A total of 88% of participating patients transitioned to medication-assisted treatment after 5 days of using the device. Additional medications used to treat specific symptoms, such as nausea and vomiting, were permitted during the trial.
The physician-placed battery-powered device sits behind the ear and uses three percutaneous electrode arrays and one single-point needle to provide neurostimulation. The electrode placement is assisted with a transillumination technique, and also is based on known neuroanatomic landmarks for branches of cranial nerves V, VII, and IX, along with branches of the occipital nerve (Clin Med Diagnostics. 2015;5[4]:70-9).
The single-use device is designed to be used for up to 5 days during acute opioid withdrawal and is contraindicated for patients with hemophilia, patients with cardiac pacemakers, or those diagnosed with psoriasis vulgaris. The NSS-2 Bridge device requires a prescription and was cleared through the de novo premarket review pathway. This, said the FDA in the press statement, is “a regulatory pathway for some low- to moderate-risk devices that are novel and for which there is no legally marketed predicate device to which the device can claim substantial equivalence.”
The NSS-2 Bridge device will be marketed by Innovative Health Solutions.
koakes@frontlinemedcom.com
On Twitter @karioakes
FDA approves dasatinib for pediatric Ph+ CML
(CML).
The tyrosine kinase inhibitor was approved for the treatment of newly diagnosed adult patients with chronic phase Ph+ CML in 2010.
Median follow-up was 4.5 years for newly diagnosed patients and 5.2 years for patients who were resistant to or intolerant of imatinib, the FDA reported. Because more than half of the responding patients had not progressed at the time of data cutoff, the investigators could not estimate median durations of complete cytogenetic response, major cytogenetic response, and major molecular response.
Adverse reactions to dasatinib included headache, nausea, diarrhea, skin rash, vomiting, pain in extremities, abdominal pain, fatigue, and arthralgia; these side effects were reported in approximately 10% of patients.
Dasatinib is marketed as Sprycel by Bristol-Myers Squibb.
The recommended dose of dasatinib for pediatric patients is based on their body weight. Full prescribing information is available here.
(CML).
The tyrosine kinase inhibitor was approved for the treatment of newly diagnosed adult patients with chronic phase Ph+ CML in 2010.
Median follow-up was 4.5 years for newly diagnosed patients and 5.2 years for patients who were resistant to or intolerant of imatinib, the FDA reported. Because more than half of the responding patients had not progressed at the time of data cutoff, the investigators could not estimate median durations of complete cytogenetic response, major cytogenetic response, and major molecular response.
Adverse reactions to dasatinib included headache, nausea, diarrhea, skin rash, vomiting, pain in extremities, abdominal pain, fatigue, and arthralgia; these side effects were reported in approximately 10% of patients.
Dasatinib is marketed as Sprycel by Bristol-Myers Squibb.
The recommended dose of dasatinib for pediatric patients is based on their body weight. Full prescribing information is available here.
(CML).
The tyrosine kinase inhibitor was approved for the treatment of newly diagnosed adult patients with chronic phase Ph+ CML in 2010.
Median follow-up was 4.5 years for newly diagnosed patients and 5.2 years for patients who were resistant to or intolerant of imatinib, the FDA reported. Because more than half of the responding patients had not progressed at the time of data cutoff, the investigators could not estimate median durations of complete cytogenetic response, major cytogenetic response, and major molecular response.
Adverse reactions to dasatinib included headache, nausea, diarrhea, skin rash, vomiting, pain in extremities, abdominal pain, fatigue, and arthralgia; these side effects were reported in approximately 10% of patients.
Dasatinib is marketed as Sprycel by Bristol-Myers Squibb.
The recommended dose of dasatinib for pediatric patients is based on their body weight. Full prescribing information is available here.
Adherence boon, or Big Brother loom?
The Food and Drug Administration has approved the first drug in the United States with a digital ingestion tracking system. Abilify MyCite (aripiprazole tablets with sensor) has an ingestible sensor embedded in the pill that records that the medication was taken. The product is approved for the treatment of schizophrenia, acute treatment of manic and mixed episodes associated with bipolar I disorder, and for use as an add-on treatment for depression in adults.
The system works by sending a message from the pill’s sensor to a wearable patch, according to a statement issued by the FDA. The patch transmits the information to a mobile application so that patients can track the ingestion of the medication on their smartphones. Patients can also permit their caregivers and physician to access the information through a web-based portal.
[polldaddy:9874958]
The Food and Drug Administration has approved the first drug in the United States with a digital ingestion tracking system. Abilify MyCite (aripiprazole tablets with sensor) has an ingestible sensor embedded in the pill that records that the medication was taken. The product is approved for the treatment of schizophrenia, acute treatment of manic and mixed episodes associated with bipolar I disorder, and for use as an add-on treatment for depression in adults.
The system works by sending a message from the pill’s sensor to a wearable patch, according to a statement issued by the FDA. The patch transmits the information to a mobile application so that patients can track the ingestion of the medication on their smartphones. Patients can also permit their caregivers and physician to access the information through a web-based portal.
[polldaddy:9874958]
The Food and Drug Administration has approved the first drug in the United States with a digital ingestion tracking system. Abilify MyCite (aripiprazole tablets with sensor) has an ingestible sensor embedded in the pill that records that the medication was taken. The product is approved for the treatment of schizophrenia, acute treatment of manic and mixed episodes associated with bipolar I disorder, and for use as an add-on treatment for depression in adults.
The system works by sending a message from the pill’s sensor to a wearable patch, according to a statement issued by the FDA. The patch transmits the information to a mobile application so that patients can track the ingestion of the medication on their smartphones. Patients can also permit their caregivers and physician to access the information through a web-based portal.
[polldaddy:9874958]
FDA approves cariprazine for schizophrenia maintenance treatment
The Food and Drug Administration has approved a supplemental new drug application for cariprazine (Vraylar) for maintenance treatment of adults with schizophrenia, the drug’s licensor, Allergan, announced Nov. 13. The drug was approved in 2015 for the acute treatment of schizophrenia or for manic or mixed episodes of bipolar I disorder in adults.
The efficacy of the atypical antipsychotic for maintenance treatment of schizophrenia was demonstrated by a 72-week multinational, double-blind, randomized study of a stabilized cariprazine dose of 3, 6, or 9 mg daily, compared with placebo. The daily dose had a significant effect on the study’s primary endpoint – time to relapse. Nearly twice as many placebo-treated patients as cariprazine-treated patients relapsed (49.5% vs. 29.7%).
“The goal of clinicians is to minimize relapses, which can cause significant personal distress and can often have serious implications for a patient’s health,” said Herbert Y. Meltzer, MD, professor of psychiatry and behavioral sciences, pharmacology, and physiology, at Northwestern University, Chicago, in the release. “The approval of Vraylar for the maintenance treatment of schizophrenia provides an important therapy for patients and physicians who are in need of long-term treatment options.”
Cariprazine may cause rash, pruritus, urticaria, and events suggestive of angioedema and is not approved for patients with dementia-related psychosis, as it has an increased mortality risk for elderly patients with dementia. In approved schizophrenia patients, it carries a risk of extrapyramidal symptoms and akathisia.
The Food and Drug Administration has approved a supplemental new drug application for cariprazine (Vraylar) for maintenance treatment of adults with schizophrenia, the drug’s licensor, Allergan, announced Nov. 13. The drug was approved in 2015 for the acute treatment of schizophrenia or for manic or mixed episodes of bipolar I disorder in adults.
The efficacy of the atypical antipsychotic for maintenance treatment of schizophrenia was demonstrated by a 72-week multinational, double-blind, randomized study of a stabilized cariprazine dose of 3, 6, or 9 mg daily, compared with placebo. The daily dose had a significant effect on the study’s primary endpoint – time to relapse. Nearly twice as many placebo-treated patients as cariprazine-treated patients relapsed (49.5% vs. 29.7%).
“The goal of clinicians is to minimize relapses, which can cause significant personal distress and can often have serious implications for a patient’s health,” said Herbert Y. Meltzer, MD, professor of psychiatry and behavioral sciences, pharmacology, and physiology, at Northwestern University, Chicago, in the release. “The approval of Vraylar for the maintenance treatment of schizophrenia provides an important therapy for patients and physicians who are in need of long-term treatment options.”
Cariprazine may cause rash, pruritus, urticaria, and events suggestive of angioedema and is not approved for patients with dementia-related psychosis, as it has an increased mortality risk for elderly patients with dementia. In approved schizophrenia patients, it carries a risk of extrapyramidal symptoms and akathisia.
The Food and Drug Administration has approved a supplemental new drug application for cariprazine (Vraylar) for maintenance treatment of adults with schizophrenia, the drug’s licensor, Allergan, announced Nov. 13. The drug was approved in 2015 for the acute treatment of schizophrenia or for manic or mixed episodes of bipolar I disorder in adults.
The efficacy of the atypical antipsychotic for maintenance treatment of schizophrenia was demonstrated by a 72-week multinational, double-blind, randomized study of a stabilized cariprazine dose of 3, 6, or 9 mg daily, compared with placebo. The daily dose had a significant effect on the study’s primary endpoint – time to relapse. Nearly twice as many placebo-treated patients as cariprazine-treated patients relapsed (49.5% vs. 29.7%).
“The goal of clinicians is to minimize relapses, which can cause significant personal distress and can often have serious implications for a patient’s health,” said Herbert Y. Meltzer, MD, professor of psychiatry and behavioral sciences, pharmacology, and physiology, at Northwestern University, Chicago, in the release. “The approval of Vraylar for the maintenance treatment of schizophrenia provides an important therapy for patients and physicians who are in need of long-term treatment options.”
Cariprazine may cause rash, pruritus, urticaria, and events suggestive of angioedema and is not approved for patients with dementia-related psychosis, as it has an increased mortality risk for elderly patients with dementia. In approved schizophrenia patients, it carries a risk of extrapyramidal symptoms and akathisia.
FDA approves Vimpat for POS treatment in children with epilepsy
The Food and Drug Administration has approved lacosamide for the treatment of partial-onset seizures in children with epilepsy, according to a statement by UCB, manufacturer of the drug.
The approval by the FDA is an extension of the drug’s previous indication, which was approved in 2009 for use in adults, and is based on four clinical trials and pharmacokinetic analyses from adult and pediatric data. The expanded indication is for children older than 4 years, and applies only to the oral tablet. Lacosamide (Vimpat) injections remain indicated only for adult patients older than 17 years.
“Until recently there were few effective treatment options approved for childhood epilepsy. This has contributed to poor seizure control for many, which can be detrimental to overall quality of life. The availability of lacosamide for children with epilepsy has the potential to change the lives of children and their families by providing an additional choice to support them in their epilepsy journey,” Raman Sankar, MD, PhD, professor of neurology and pediatrics and chief of pediatric neurology at the University of California, Los Angeles, said in the statement.
Find the full press release on the UCB website.
The Food and Drug Administration has approved lacosamide for the treatment of partial-onset seizures in children with epilepsy, according to a statement by UCB, manufacturer of the drug.
The approval by the FDA is an extension of the drug’s previous indication, which was approved in 2009 for use in adults, and is based on four clinical trials and pharmacokinetic analyses from adult and pediatric data. The expanded indication is for children older than 4 years, and applies only to the oral tablet. Lacosamide (Vimpat) injections remain indicated only for adult patients older than 17 years.
“Until recently there were few effective treatment options approved for childhood epilepsy. This has contributed to poor seizure control for many, which can be detrimental to overall quality of life. The availability of lacosamide for children with epilepsy has the potential to change the lives of children and their families by providing an additional choice to support them in their epilepsy journey,” Raman Sankar, MD, PhD, professor of neurology and pediatrics and chief of pediatric neurology at the University of California, Los Angeles, said in the statement.
Find the full press release on the UCB website.
The Food and Drug Administration has approved lacosamide for the treatment of partial-onset seizures in children with epilepsy, according to a statement by UCB, manufacturer of the drug.
The approval by the FDA is an extension of the drug’s previous indication, which was approved in 2009 for use in adults, and is based on four clinical trials and pharmacokinetic analyses from adult and pediatric data. The expanded indication is for children older than 4 years, and applies only to the oral tablet. Lacosamide (Vimpat) injections remain indicated only for adult patients older than 17 years.
The most common adverse events associated with lacosamide are dizziness, headache, nausea, and diplopia. In addition, antiepileptic drugs such as lacosamide are associated with an increased risk of suicidal behavior or ideation, and patients should be monitored for new or worsening depression.
“Until recently there were few effective treatment options approved for childhood epilepsy. This has contributed to poor seizure control for many, which can be detrimental to overall quality of life. The availability of lacosamide for children with epilepsy has the potential to change the lives of children and their families by providing an additional choice to support them in their epilepsy journey,” Raman Sankar, MD, PhD, professor of neurology and pediatrics and chief of pediatric neurology at the University of California, Los Angeles, said in the statement.
Find the full press release on the UCB website.
FDA approves Cinvanti for chemo-induced nausea and vomiting
The Food and Drug Administration has approved aprepitant injectable emulsion for the prevention of acute and delayed chemotherapy-induced nausea and vomiting (CINV), Heron Therapeutics announced Nov. 9.
“CINV remains a high unmet medical need in the oncology community, and five full days of CINV coverage continues to be our goal,” Heron CEO Jeffrey Patton, MD, said in a statement. “NK1 receptor antagonists are recommended for routine use with [highly emetogenic chemotherapy] and are a recommended option with [moderately emetogenic chemotherapy]. Despite this, NK1 receptor antagonists are underutilized in CINV.”
Aprepitant injectable emulsion is indicated specifically for acute and delayed nausea and vomiting associated with initial and repeated courses of highly emetogenic chemotherapy, including high-dose cisplatin. Treatment is a single dose of 130 mg via intravenous infusion on day 1, approximately 30 minutes before chemotherapy is initiated. It is also indicated for use in moderately emetogenic chemotherapy; treatment of these patients is 100 mg on day 1, followed by oral aprepitant on days 2 and 3.
The most common adverse reactions with single-dose aprepitant injectable emulsion were headache and fatigue.
Aprepitant injectable emulsion will be marketed as Cinvanti and is expected to be available in January 2018, according to the company.
The Food and Drug Administration has approved aprepitant injectable emulsion for the prevention of acute and delayed chemotherapy-induced nausea and vomiting (CINV), Heron Therapeutics announced Nov. 9.
“CINV remains a high unmet medical need in the oncology community, and five full days of CINV coverage continues to be our goal,” Heron CEO Jeffrey Patton, MD, said in a statement. “NK1 receptor antagonists are recommended for routine use with [highly emetogenic chemotherapy] and are a recommended option with [moderately emetogenic chemotherapy]. Despite this, NK1 receptor antagonists are underutilized in CINV.”
Aprepitant injectable emulsion is indicated specifically for acute and delayed nausea and vomiting associated with initial and repeated courses of highly emetogenic chemotherapy, including high-dose cisplatin. Treatment is a single dose of 130 mg via intravenous infusion on day 1, approximately 30 minutes before chemotherapy is initiated. It is also indicated for use in moderately emetogenic chemotherapy; treatment of these patients is 100 mg on day 1, followed by oral aprepitant on days 2 and 3.
The most common adverse reactions with single-dose aprepitant injectable emulsion were headache and fatigue.
Aprepitant injectable emulsion will be marketed as Cinvanti and is expected to be available in January 2018, according to the company.
The Food and Drug Administration has approved aprepitant injectable emulsion for the prevention of acute and delayed chemotherapy-induced nausea and vomiting (CINV), Heron Therapeutics announced Nov. 9.
“CINV remains a high unmet medical need in the oncology community, and five full days of CINV coverage continues to be our goal,” Heron CEO Jeffrey Patton, MD, said in a statement. “NK1 receptor antagonists are recommended for routine use with [highly emetogenic chemotherapy] and are a recommended option with [moderately emetogenic chemotherapy]. Despite this, NK1 receptor antagonists are underutilized in CINV.”
Aprepitant injectable emulsion is indicated specifically for acute and delayed nausea and vomiting associated with initial and repeated courses of highly emetogenic chemotherapy, including high-dose cisplatin. Treatment is a single dose of 130 mg via intravenous infusion on day 1, approximately 30 minutes before chemotherapy is initiated. It is also indicated for use in moderately emetogenic chemotherapy; treatment of these patients is 100 mg on day 1, followed by oral aprepitant on days 2 and 3.
The most common adverse reactions with single-dose aprepitant injectable emulsion were headache and fatigue.
Aprepitant injectable emulsion will be marketed as Cinvanti and is expected to be available in January 2018, according to the company.
FDA approves first two-dose HBV vaccine
When the Food and Drug Administration approved Heplisav-B Nov. 9, it marked the first new vaccine for hepatitis B virus (HBV) to be sanctioned in over 25 years.
Heplisav-B is the only two-dose regimen that protects against all known subtypes of HBV in adults 18 years and older, according to a statement released by Dynavax Technologies, the creator of the drug.
“Heplisav-B is the first FDA-approved product for Dynavax and demonstrates our ability to develop innovative products and progress them from discovery to commercialization,” according to Eddie Gray, chief executive officer of Dynavax. “We expect that it will become an essential tool in the public health community’s fight to prevent hepatitis B [infection], and we look forward to making Heplisav-B available to clinicians and their adult patients.”
Incidence of HBV has increased sharply from 2012 to 2015 in the United States, with reported cases rising from 2,895 to 3,370, according to the Centers for Disease Control and Prevention.
From 2014 to 2015, acute HBV infection increased 20.7%, according to the CDC report.
The new vaccine’s approval came after review of safety and efficacy data from three phase 3 trials comparing Heplisav-B with Engerix-B, another HBV vaccine currently available, that is given in a three-dose regimen.
In one study of 2,032 patients between the ages of 18 and 55 years, seroprotection rate in the Heplisav-B group (1,511) was 95%, compared with 81.5% in the Engerix-B group (521).
Heplisav-B patients were given a two-dose regimen of the drug at 0 and 1 months, followed by a placebo at 6 months, while investigators administered Engerix-B at all three intervals in the comparator subjects.
The FDA’s decision to green-light the new vaccine follows a recommendation for approval from the FDA’s Vaccines and Related Biological Products Advisory Committee, held at the end of July this year.
During the advisory committee meeting, members were concerned about an increased relative risk for acute myocardial infarction of 6.97 in Heplisav-B patients (14), compared with Engerix-B patients (1).
The recommendation for approval came with the caveat of conducting postmarketing analysis for the risk of AMI in Heplisav-B patients, which Dynavax is conducting through the Kaiser Permanente system in California.
“To evaluate the risk of AMIs, the study will enroll 25,000 Heplisav-B patients and 25,000 Engerix-B patients over approximately 10 months and follow them for 1 year after vaccination,” according to a statement from Dynavax. “In addition we will evaluate the rate of immune-mediated diseases in these patients in an additional 5,000 Heplisav-B recipients and 5,000 Engerix-B recipients.”
Dynavax is currently set to introduce Heplisav-B commercially in the United States in 2018, with the cost of the drug set to be released soon.
“Dynavax is in the process of finalizing the price of a two-dose series of Heplisav-B, and they plan to disclose it shortly after approval,” according to the company. “Their pricing and access strategy will be aimed at ensuring that populations at risk of infection are able to access this new vaccine, while recognizing the value it brings to the health care system with a two-dose regimen and higher rates of protection compared to Engerix-B.”
ezimmerman@frontlinemedcom.com
On Twitter @eaztweets
When the Food and Drug Administration approved Heplisav-B Nov. 9, it marked the first new vaccine for hepatitis B virus (HBV) to be sanctioned in over 25 years.
Heplisav-B is the only two-dose regimen that protects against all known subtypes of HBV in adults 18 years and older, according to a statement released by Dynavax Technologies, the creator of the drug.
“Heplisav-B is the first FDA-approved product for Dynavax and demonstrates our ability to develop innovative products and progress them from discovery to commercialization,” according to Eddie Gray, chief executive officer of Dynavax. “We expect that it will become an essential tool in the public health community’s fight to prevent hepatitis B [infection], and we look forward to making Heplisav-B available to clinicians and their adult patients.”
Incidence of HBV has increased sharply from 2012 to 2015 in the United States, with reported cases rising from 2,895 to 3,370, according to the Centers for Disease Control and Prevention.
From 2014 to 2015, acute HBV infection increased 20.7%, according to the CDC report.
The new vaccine’s approval came after review of safety and efficacy data from three phase 3 trials comparing Heplisav-B with Engerix-B, another HBV vaccine currently available, that is given in a three-dose regimen.
In one study of 2,032 patients between the ages of 18 and 55 years, seroprotection rate in the Heplisav-B group (1,511) was 95%, compared with 81.5% in the Engerix-B group (521).
Heplisav-B patients were given a two-dose regimen of the drug at 0 and 1 months, followed by a placebo at 6 months, while investigators administered Engerix-B at all three intervals in the comparator subjects.
The FDA’s decision to green-light the new vaccine follows a recommendation for approval from the FDA’s Vaccines and Related Biological Products Advisory Committee, held at the end of July this year.
During the advisory committee meeting, members were concerned about an increased relative risk for acute myocardial infarction of 6.97 in Heplisav-B patients (14), compared with Engerix-B patients (1).
The recommendation for approval came with the caveat of conducting postmarketing analysis for the risk of AMI in Heplisav-B patients, which Dynavax is conducting through the Kaiser Permanente system in California.
“To evaluate the risk of AMIs, the study will enroll 25,000 Heplisav-B patients and 25,000 Engerix-B patients over approximately 10 months and follow them for 1 year after vaccination,” according to a statement from Dynavax. “In addition we will evaluate the rate of immune-mediated diseases in these patients in an additional 5,000 Heplisav-B recipients and 5,000 Engerix-B recipients.”
Dynavax is currently set to introduce Heplisav-B commercially in the United States in 2018, with the cost of the drug set to be released soon.
“Dynavax is in the process of finalizing the price of a two-dose series of Heplisav-B, and they plan to disclose it shortly after approval,” according to the company. “Their pricing and access strategy will be aimed at ensuring that populations at risk of infection are able to access this new vaccine, while recognizing the value it brings to the health care system with a two-dose regimen and higher rates of protection compared to Engerix-B.”
ezimmerman@frontlinemedcom.com
On Twitter @eaztweets
When the Food and Drug Administration approved Heplisav-B Nov. 9, it marked the first new vaccine for hepatitis B virus (HBV) to be sanctioned in over 25 years.
Heplisav-B is the only two-dose regimen that protects against all known subtypes of HBV in adults 18 years and older, according to a statement released by Dynavax Technologies, the creator of the drug.
“Heplisav-B is the first FDA-approved product for Dynavax and demonstrates our ability to develop innovative products and progress them from discovery to commercialization,” according to Eddie Gray, chief executive officer of Dynavax. “We expect that it will become an essential tool in the public health community’s fight to prevent hepatitis B [infection], and we look forward to making Heplisav-B available to clinicians and their adult patients.”
Incidence of HBV has increased sharply from 2012 to 2015 in the United States, with reported cases rising from 2,895 to 3,370, according to the Centers for Disease Control and Prevention.
From 2014 to 2015, acute HBV infection increased 20.7%, according to the CDC report.
The new vaccine’s approval came after review of safety and efficacy data from three phase 3 trials comparing Heplisav-B with Engerix-B, another HBV vaccine currently available, that is given in a three-dose regimen.
In one study of 2,032 patients between the ages of 18 and 55 years, seroprotection rate in the Heplisav-B group (1,511) was 95%, compared with 81.5% in the Engerix-B group (521).
Heplisav-B patients were given a two-dose regimen of the drug at 0 and 1 months, followed by a placebo at 6 months, while investigators administered Engerix-B at all three intervals in the comparator subjects.
The FDA’s decision to green-light the new vaccine follows a recommendation for approval from the FDA’s Vaccines and Related Biological Products Advisory Committee, held at the end of July this year.
During the advisory committee meeting, members were concerned about an increased relative risk for acute myocardial infarction of 6.97 in Heplisav-B patients (14), compared with Engerix-B patients (1).
The recommendation for approval came with the caveat of conducting postmarketing analysis for the risk of AMI in Heplisav-B patients, which Dynavax is conducting through the Kaiser Permanente system in California.
“To evaluate the risk of AMIs, the study will enroll 25,000 Heplisav-B patients and 25,000 Engerix-B patients over approximately 10 months and follow them for 1 year after vaccination,” according to a statement from Dynavax. “In addition we will evaluate the rate of immune-mediated diseases in these patients in an additional 5,000 Heplisav-B recipients and 5,000 Engerix-B recipients.”
Dynavax is currently set to introduce Heplisav-B commercially in the United States in 2018, with the cost of the drug set to be released soon.
“Dynavax is in the process of finalizing the price of a two-dose series of Heplisav-B, and they plan to disclose it shortly after approval,” according to the company. “Their pricing and access strategy will be aimed at ensuring that populations at risk of infection are able to access this new vaccine, while recognizing the value it brings to the health care system with a two-dose regimen and higher rates of protection compared to Engerix-B.”
ezimmerman@frontlinemedcom.com
On Twitter @eaztweets
FDA approves letermovir for CMV prophylaxis
The Food and Drug Administration on Nov. 8 approved the use of letermovir (Prevymis) tablets and injections for the prevention of cytomegalovirus (CMV) infection and disease in adults exposed to the virus who have received an allogeneic hematopoietic stem cell transplant (HSCT). This is the first drug to be approved for this purpose. It had previously been granted Breakthrough Therapy and Orphan Drug designation.
CMV infection is a major risk for patients undergoing HSCT, because an estimated 65%-80% of these patients already have been exposed to the virus.
Side effects associated with the use of letermovir include nausea, diarrhea, vomiting, swelling in the arms and legs, cough, headache, tiredness, and abdominal pain. The drug is contraindicated for patients receiving pimozide and ergot alkaloids, or pitavastatin or simvastatin when coadministered with cyclosporine. Prescribing information is available at the FDA website.
The Food and Drug Administration on Nov. 8 approved the use of letermovir (Prevymis) tablets and injections for the prevention of cytomegalovirus (CMV) infection and disease in adults exposed to the virus who have received an allogeneic hematopoietic stem cell transplant (HSCT). This is the first drug to be approved for this purpose. It had previously been granted Breakthrough Therapy and Orphan Drug designation.
CMV infection is a major risk for patients undergoing HSCT, because an estimated 65%-80% of these patients already have been exposed to the virus.
Side effects associated with the use of letermovir include nausea, diarrhea, vomiting, swelling in the arms and legs, cough, headache, tiredness, and abdominal pain. The drug is contraindicated for patients receiving pimozide and ergot alkaloids, or pitavastatin or simvastatin when coadministered with cyclosporine. Prescribing information is available at the FDA website.
The Food and Drug Administration on Nov. 8 approved the use of letermovir (Prevymis) tablets and injections for the prevention of cytomegalovirus (CMV) infection and disease in adults exposed to the virus who have received an allogeneic hematopoietic stem cell transplant (HSCT). This is the first drug to be approved for this purpose. It had previously been granted Breakthrough Therapy and Orphan Drug designation.
CMV infection is a major risk for patients undergoing HSCT, because an estimated 65%-80% of these patients already have been exposed to the virus.
Side effects associated with the use of letermovir include nausea, diarrhea, vomiting, swelling in the arms and legs, cough, headache, tiredness, and abdominal pain. The drug is contraindicated for patients receiving pimozide and ergot alkaloids, or pitavastatin or simvastatin when coadministered with cyclosporine. Prescribing information is available at the FDA website.