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FDA approves Orsiro stent for coronary artery disease
The Food and Drug Administration has approved Orsiro, an ultrathin drug-eluting stent (DES), for the treatment of coronary artery disease.
FDA approval was based on 2-year results from BIOFLOW-V, an international, randomized trial in 1,344 patients with coronary artery disease who received either Orsiro or Xience, the current clinical standard. At 2 years, patients who received Orsiro had a 37% lower target lesion failure rate, a 47% lower ischemia-driven target lesion revascularization rate, and a 70% lower spontaneous MI rate. These results were published in the Journal of the American College of Cardiology and presented at the Transcatheter Cardiovascular Therapeutics annual meeting in November 2018.
Orsiro previously received CE marking in Europe in 2011 and has been used to treat more than 1 million patients. The device elutes sirolimus and is available in 52 sizes ranging from 2.25 to 4.0 mm in diameter and lengths up to 40 mm, according to Biotronik’s press release.
“Orsiro has set a new standard for safety and efficacy clinical endpoints, including statistically lower target lesion revascularization and target vessel MI rates. BIOFLOW-V data are the best clinical outcomes witnessed with modern DES. It was largely thought that efficacy findings were unsurpassable, but Orsiro proves we can further reduce event rates with meaningful innovation,” David Kandzari, MD, a cardiologist at Piedmont Heart Institute in Atlanta and principal U.S. investigator for BIOFLOW-V, said in the press release.
The Food and Drug Administration has approved Orsiro, an ultrathin drug-eluting stent (DES), for the treatment of coronary artery disease.
FDA approval was based on 2-year results from BIOFLOW-V, an international, randomized trial in 1,344 patients with coronary artery disease who received either Orsiro or Xience, the current clinical standard. At 2 years, patients who received Orsiro had a 37% lower target lesion failure rate, a 47% lower ischemia-driven target lesion revascularization rate, and a 70% lower spontaneous MI rate. These results were published in the Journal of the American College of Cardiology and presented at the Transcatheter Cardiovascular Therapeutics annual meeting in November 2018.
Orsiro previously received CE marking in Europe in 2011 and has been used to treat more than 1 million patients. The device elutes sirolimus and is available in 52 sizes ranging from 2.25 to 4.0 mm in diameter and lengths up to 40 mm, according to Biotronik’s press release.
“Orsiro has set a new standard for safety and efficacy clinical endpoints, including statistically lower target lesion revascularization and target vessel MI rates. BIOFLOW-V data are the best clinical outcomes witnessed with modern DES. It was largely thought that efficacy findings were unsurpassable, but Orsiro proves we can further reduce event rates with meaningful innovation,” David Kandzari, MD, a cardiologist at Piedmont Heart Institute in Atlanta and principal U.S. investigator for BIOFLOW-V, said in the press release.
The Food and Drug Administration has approved Orsiro, an ultrathin drug-eluting stent (DES), for the treatment of coronary artery disease.
FDA approval was based on 2-year results from BIOFLOW-V, an international, randomized trial in 1,344 patients with coronary artery disease who received either Orsiro or Xience, the current clinical standard. At 2 years, patients who received Orsiro had a 37% lower target lesion failure rate, a 47% lower ischemia-driven target lesion revascularization rate, and a 70% lower spontaneous MI rate. These results were published in the Journal of the American College of Cardiology and presented at the Transcatheter Cardiovascular Therapeutics annual meeting in November 2018.
Orsiro previously received CE marking in Europe in 2011 and has been used to treat more than 1 million patients. The device elutes sirolimus and is available in 52 sizes ranging from 2.25 to 4.0 mm in diameter and lengths up to 40 mm, according to Biotronik’s press release.
“Orsiro has set a new standard for safety and efficacy clinical endpoints, including statistically lower target lesion revascularization and target vessel MI rates. BIOFLOW-V data are the best clinical outcomes witnessed with modern DES. It was largely thought that efficacy findings were unsurpassable, but Orsiro proves we can further reduce event rates with meaningful innovation,” David Kandzari, MD, a cardiologist at Piedmont Heart Institute in Atlanta and principal U.S. investigator for BIOFLOW-V, said in the press release.
FDA approves combo Lonsurf for gastric and GEJ adenocarcinomas
The Food and Drug Administration has approved Taiho’s trifluridine/tipiracil combination Lonsurf for adult patients with either gastric or gastroesophageal junction adenocarcinomas. Specifically, these patients will have been previously treated with at least two lines of chemotherapy that included fluoropyrimidine, a platinum, either a taxane or irinotecan, and if appropriate, HER2/neu-targeted therapy, according to a statement from the company.
The approval was based on the TAGS trial (NCT02500043), which was a global, randomized, phase 3 study that evaluated Lonsurf plus best supportive care versus placebo plus best supportive care. The trial demonstrated prolonged overall survival with the drug combo, compared with that seen with placebo, and thereby met its primary and secondary endpoint. The safety profile seen in the trial was consistent with what’s previously been seen with the drug. Results from this trial were published in The Lancet Oncology.
Warnings and precautions for the drug combination include severe myelosuppression and embryo-fetal toxicity, as well as fatigue, nausea, diarrhea, infections, pyrexia, alopecia, and others. The full prescribing information can be found on the Taiho website.
The Food and Drug Administration has approved Taiho’s trifluridine/tipiracil combination Lonsurf for adult patients with either gastric or gastroesophageal junction adenocarcinomas. Specifically, these patients will have been previously treated with at least two lines of chemotherapy that included fluoropyrimidine, a platinum, either a taxane or irinotecan, and if appropriate, HER2/neu-targeted therapy, according to a statement from the company.
The approval was based on the TAGS trial (NCT02500043), which was a global, randomized, phase 3 study that evaluated Lonsurf plus best supportive care versus placebo plus best supportive care. The trial demonstrated prolonged overall survival with the drug combo, compared with that seen with placebo, and thereby met its primary and secondary endpoint. The safety profile seen in the trial was consistent with what’s previously been seen with the drug. Results from this trial were published in The Lancet Oncology.
Warnings and precautions for the drug combination include severe myelosuppression and embryo-fetal toxicity, as well as fatigue, nausea, diarrhea, infections, pyrexia, alopecia, and others. The full prescribing information can be found on the Taiho website.
The Food and Drug Administration has approved Taiho’s trifluridine/tipiracil combination Lonsurf for adult patients with either gastric or gastroesophageal junction adenocarcinomas. Specifically, these patients will have been previously treated with at least two lines of chemotherapy that included fluoropyrimidine, a platinum, either a taxane or irinotecan, and if appropriate, HER2/neu-targeted therapy, according to a statement from the company.
The approval was based on the TAGS trial (NCT02500043), which was a global, randomized, phase 3 study that evaluated Lonsurf plus best supportive care versus placebo plus best supportive care. The trial demonstrated prolonged overall survival with the drug combo, compared with that seen with placebo, and thereby met its primary and secondary endpoint. The safety profile seen in the trial was consistent with what’s previously been seen with the drug. Results from this trial were published in The Lancet Oncology.
Warnings and precautions for the drug combination include severe myelosuppression and embryo-fetal toxicity, as well as fatigue, nausea, diarrhea, infections, pyrexia, alopecia, and others. The full prescribing information can be found on the Taiho website.
FDA clears test to monitor residual disease in CML
The Food and Drug Administration has cleared Bio-Rad’s digital polymerase chain reaction (PCR) testing solution to monitor patients’ molecular response to treatment for chronic myeloid leukemia.
The QXDx AutoDG ddPCR System combines Bio-Rad’s Droplet Digital PCR technology and the QXDx BCR-ABL %IS Kit, according to the company.
This so-called liquid biopsy test can “precisely and reproducibly” monitor the molecular response to tyrosine kinase inhibitor therapy. The current standard – reverse transcription quantitative PCR – can have variable results, especially at low levels of disease, according to Bio-Rad.
FDA clearance means that the product is “substantially equivalent” to an already-approved product and can be sold in the United States, according to the agency.
The Food and Drug Administration has cleared Bio-Rad’s digital polymerase chain reaction (PCR) testing solution to monitor patients’ molecular response to treatment for chronic myeloid leukemia.
The QXDx AutoDG ddPCR System combines Bio-Rad’s Droplet Digital PCR technology and the QXDx BCR-ABL %IS Kit, according to the company.
This so-called liquid biopsy test can “precisely and reproducibly” monitor the molecular response to tyrosine kinase inhibitor therapy. The current standard – reverse transcription quantitative PCR – can have variable results, especially at low levels of disease, according to Bio-Rad.
FDA clearance means that the product is “substantially equivalent” to an already-approved product and can be sold in the United States, according to the agency.
The Food and Drug Administration has cleared Bio-Rad’s digital polymerase chain reaction (PCR) testing solution to monitor patients’ molecular response to treatment for chronic myeloid leukemia.
The QXDx AutoDG ddPCR System combines Bio-Rad’s Droplet Digital PCR technology and the QXDx BCR-ABL %IS Kit, according to the company.
This so-called liquid biopsy test can “precisely and reproducibly” monitor the molecular response to tyrosine kinase inhibitor therapy. The current standard – reverse transcription quantitative PCR – can have variable results, especially at low levels of disease, according to Bio-Rad.
FDA clearance means that the product is “substantially equivalent” to an already-approved product and can be sold in the United States, according to the agency.
Death data spur black-box warning for gout drug Uloric
, the Food and Drug Administration declared on Feb. 21. The agency is now mandating a black-box warning.
“Health care professionals should reserve Uloric for use only in patients who have failed or do not tolerate allopurinol,” the FDA announced. “Counsel patients about the cardiovascular risk with Uloric,” the agency suggested, and advise them to seek medical attention at once if they have cardiac symptoms such as chest pain, shortness of breath, rapid or irregular heartbeat, or dizziness.
The FDA’s move comes a decade after it approved febuxostat as a gout treatment. As the FDA noted in its announcement, “the number of medicines to treat gout is limited, and there is an unmet need for treatments for this disease.”
Research has suggested that both febuxostat and allopurinol have similar efficacy. Some experts have recommended febuxostat as an alternative for patients who shouldn’t take allopurinol (Semin Arthritis Rheum. 2013 Dec;43[3]:367-75).
However, research has raised concerns about febuxostat’s cardiac risk. In its Feb. 21 statement, the FDA pointed to the findings of a 2010-2017 postmarket clinical trial of 6,190 patients with gout who were treated with febuxostat or allopurinol (N Engl J Med. 2018;378:1200-10).
“In patients treated with Uloric, 15 deaths from heart-related causes were observed for every 1,000 patients treated for a year compared to 11 deaths from heart-related causes per 1,000 patients treated with allopurinol for a year,” the FDA said. “In addition, there were 26 deaths from any cause per 1,000 patients treated for a year with Uloric compared to 22 deaths per 1,000 patients treated for a year with allopurinol.”
, the Food and Drug Administration declared on Feb. 21. The agency is now mandating a black-box warning.
“Health care professionals should reserve Uloric for use only in patients who have failed or do not tolerate allopurinol,” the FDA announced. “Counsel patients about the cardiovascular risk with Uloric,” the agency suggested, and advise them to seek medical attention at once if they have cardiac symptoms such as chest pain, shortness of breath, rapid or irregular heartbeat, or dizziness.
The FDA’s move comes a decade after it approved febuxostat as a gout treatment. As the FDA noted in its announcement, “the number of medicines to treat gout is limited, and there is an unmet need for treatments for this disease.”
Research has suggested that both febuxostat and allopurinol have similar efficacy. Some experts have recommended febuxostat as an alternative for patients who shouldn’t take allopurinol (Semin Arthritis Rheum. 2013 Dec;43[3]:367-75).
However, research has raised concerns about febuxostat’s cardiac risk. In its Feb. 21 statement, the FDA pointed to the findings of a 2010-2017 postmarket clinical trial of 6,190 patients with gout who were treated with febuxostat or allopurinol (N Engl J Med. 2018;378:1200-10).
“In patients treated with Uloric, 15 deaths from heart-related causes were observed for every 1,000 patients treated for a year compared to 11 deaths from heart-related causes per 1,000 patients treated with allopurinol for a year,” the FDA said. “In addition, there were 26 deaths from any cause per 1,000 patients treated for a year with Uloric compared to 22 deaths per 1,000 patients treated for a year with allopurinol.”
, the Food and Drug Administration declared on Feb. 21. The agency is now mandating a black-box warning.
“Health care professionals should reserve Uloric for use only in patients who have failed or do not tolerate allopurinol,” the FDA announced. “Counsel patients about the cardiovascular risk with Uloric,” the agency suggested, and advise them to seek medical attention at once if they have cardiac symptoms such as chest pain, shortness of breath, rapid or irregular heartbeat, or dizziness.
The FDA’s move comes a decade after it approved febuxostat as a gout treatment. As the FDA noted in its announcement, “the number of medicines to treat gout is limited, and there is an unmet need for treatments for this disease.”
Research has suggested that both febuxostat and allopurinol have similar efficacy. Some experts have recommended febuxostat as an alternative for patients who shouldn’t take allopurinol (Semin Arthritis Rheum. 2013 Dec;43[3]:367-75).
However, research has raised concerns about febuxostat’s cardiac risk. In its Feb. 21 statement, the FDA pointed to the findings of a 2010-2017 postmarket clinical trial of 6,190 patients with gout who were treated with febuxostat or allopurinol (N Engl J Med. 2018;378:1200-10).
“In patients treated with Uloric, 15 deaths from heart-related causes were observed for every 1,000 patients treated for a year compared to 11 deaths from heart-related causes per 1,000 patients treated with allopurinol for a year,” the FDA said. “In addition, there were 26 deaths from any cause per 1,000 patients treated for a year with Uloric compared to 22 deaths per 1,000 patients treated for a year with allopurinol.”
FDA: More safety data needed for 12 sunscreen active ingredients
including some of those frequently used in over-the-counter products.
The ingredients requiring additional investigation are cinoxate, dioxybenzone, ensulizole, homosalate, meradimate, octinoxate, octisalate, octocrylene, padimate O, sulisobenzone, oxybenzone, and avobenzone. The FDA actions were announced during a press briefing Feb. 21 held to discuss the proposed rule to update regulatory requirements for most sunscreen products marketed in the United States.
There are no urgent safety matters associated with these ingredients. The rule is part of FDA’s charge to construct an over-the-counter (OTC) monograph detailing all available data on sunscreen ingredients, as required by the Sunscreen Innovation Act.
OTC monographs establish conditions under which ingredients may be marketed without approved new drug applications because they are generally recognized as safe and effective (GRASE) “and not misbranded,” according to the FDA. The proposed rule classifies active ingredients and other conditions as Category I (proposed to be GRASE and not misbranded), Category II (proposed to be not GRASE or to be misbranded), or Category III (additional data needed).
“We are proposing that these ingredients require additional data before a positive GRASE determination can be made,” FDA press officer Sandy Walsh said in an interview, referring to the 12 ingredients. “This proposed rule does not represent a conclusion by the FDA that the sunscreen active ingredients proposed as having insufficient data are unsafe for use in sunscreens. Rather, we are requesting additional information on these ingredients so that we can evaluate their GRASE status in light of changed conditions, including substantially increased sunscreen usage and evolving information about the potential risks associated with these products since they were originally evaluated.”
Among its provisions, the proposal addresses sunscreen active-ingredient safety, dosage forms, and sun protection factor (SPF) and broad-spectrum requirements. It also proposes updates to how products are labeled to make it easier for consumers to identify key product information
Thus far, the agency says that only two active ingredients – titanium dioxide and zinc oxide – can be marketed without approved new drug applications because they are GRASE.
However, two other ingredients – PABA and trolamine salicylate – are not GRASE for use in sunscreens because of safety issues, Theresa Michele, MD, director of the Division of Nonprescription Drug Products Division of Nonprescription Drug Products in the FDA’s Center for Drug Evaluation and Research. Products that combine sunscreen and insect repellent also not fit the criteria, she said
“There are 12 ingredients for which there are insufficient safety data to make a positive GRASE determination at this time. To address these 12 ingredients, the FDA is asking industry and other interested parties for additional data. The FDA is working closely with industry and has published several guidances to make sure companies understand what data the agency believes is necessary for the FDA to evaluate safety and effectiveness for sunscreen active ingredients, including the 12 ingredients for which the FDA is seeking more data,” she said.
In addition to seeking these additional data, the rule also proposes the following:
- Dosage forms that are GRASE for use as sunscreens should include sprays, oils, lotions, creams, gels, butters, pastes, ointments, and sticks. While powders are proposed to be eligible for inclusion in the monograph, more data are being requested before powders are included. “Wipes, towelettes, body washes, shampoos, and other dosage forms are proposed to be categorized as new drugs because the FDA has not received data showing they are eligible for inclusion in the monograph,” according to the FDA statement outlining the proposed regulation.
- The maximum proposed SPF value on sunscreen labels should be raised from SPF 50 or higher to SPF 60 or higher. “There are not enough data to suggest that consumers get any extra benefit from products with an SPF of more than 60,” Dr. Michele said.
- Sunscreens with an SPF value of 15 or higher should be required to also provide broad-spectrum protection, and for broad-spectrum products, as SPF increases, the magnitude of protection against UVA radiation should also increase. “These proposals are designed to ensure that these products provide consumers with the protections that they expect,” the statement said.
- New sunscreen product labels should be required to make it easier for consumers to identify important information, “including the addition of the active ingredients on the front of the package to bring sunscreen in line with other OTC drugs; a notification on the front label for consumers to read the skin cancer/skin aging alert for sunscreens that have not been shown to help prevent skin cancer; and revised formats for SPF, broad spectrum, and water resistance statements,” the statement said.
- Products that combine sunscreens with insect repellents are not GRASE.
In the meantime, though, consumers should continue to use sunscreens regularly as part of a comprehensive sun protection program, FDA Commissioner Scott Gottlieb, MD, said during the briefing. “Broad spectrum sunscreens with SPF values of at least 15 are critical to the arsenal of tools for preventing skin cancer and protecting the skin from damage caused by the sun’s rays,” he continued. “Given the recognized public health benefits of sunscreen use, Americans should continue to use sunscreens in conjunction with other sun protective measures (such as protective clothing) as this important rule-making effort moves forward.”
To submit comments on this proposed rule, go to https://www.regulations.gov and follow instructions for submitting comments.
including some of those frequently used in over-the-counter products.
The ingredients requiring additional investigation are cinoxate, dioxybenzone, ensulizole, homosalate, meradimate, octinoxate, octisalate, octocrylene, padimate O, sulisobenzone, oxybenzone, and avobenzone. The FDA actions were announced during a press briefing Feb. 21 held to discuss the proposed rule to update regulatory requirements for most sunscreen products marketed in the United States.
There are no urgent safety matters associated with these ingredients. The rule is part of FDA’s charge to construct an over-the-counter (OTC) monograph detailing all available data on sunscreen ingredients, as required by the Sunscreen Innovation Act.
OTC monographs establish conditions under which ingredients may be marketed without approved new drug applications because they are generally recognized as safe and effective (GRASE) “and not misbranded,” according to the FDA. The proposed rule classifies active ingredients and other conditions as Category I (proposed to be GRASE and not misbranded), Category II (proposed to be not GRASE or to be misbranded), or Category III (additional data needed).
“We are proposing that these ingredients require additional data before a positive GRASE determination can be made,” FDA press officer Sandy Walsh said in an interview, referring to the 12 ingredients. “This proposed rule does not represent a conclusion by the FDA that the sunscreen active ingredients proposed as having insufficient data are unsafe for use in sunscreens. Rather, we are requesting additional information on these ingredients so that we can evaluate their GRASE status in light of changed conditions, including substantially increased sunscreen usage and evolving information about the potential risks associated with these products since they were originally evaluated.”
Among its provisions, the proposal addresses sunscreen active-ingredient safety, dosage forms, and sun protection factor (SPF) and broad-spectrum requirements. It also proposes updates to how products are labeled to make it easier for consumers to identify key product information
Thus far, the agency says that only two active ingredients – titanium dioxide and zinc oxide – can be marketed without approved new drug applications because they are GRASE.
However, two other ingredients – PABA and trolamine salicylate – are not GRASE for use in sunscreens because of safety issues, Theresa Michele, MD, director of the Division of Nonprescription Drug Products Division of Nonprescription Drug Products in the FDA’s Center for Drug Evaluation and Research. Products that combine sunscreen and insect repellent also not fit the criteria, she said
“There are 12 ingredients for which there are insufficient safety data to make a positive GRASE determination at this time. To address these 12 ingredients, the FDA is asking industry and other interested parties for additional data. The FDA is working closely with industry and has published several guidances to make sure companies understand what data the agency believes is necessary for the FDA to evaluate safety and effectiveness for sunscreen active ingredients, including the 12 ingredients for which the FDA is seeking more data,” she said.
In addition to seeking these additional data, the rule also proposes the following:
- Dosage forms that are GRASE for use as sunscreens should include sprays, oils, lotions, creams, gels, butters, pastes, ointments, and sticks. While powders are proposed to be eligible for inclusion in the monograph, more data are being requested before powders are included. “Wipes, towelettes, body washes, shampoos, and other dosage forms are proposed to be categorized as new drugs because the FDA has not received data showing they are eligible for inclusion in the monograph,” according to the FDA statement outlining the proposed regulation.
- The maximum proposed SPF value on sunscreen labels should be raised from SPF 50 or higher to SPF 60 or higher. “There are not enough data to suggest that consumers get any extra benefit from products with an SPF of more than 60,” Dr. Michele said.
- Sunscreens with an SPF value of 15 or higher should be required to also provide broad-spectrum protection, and for broad-spectrum products, as SPF increases, the magnitude of protection against UVA radiation should also increase. “These proposals are designed to ensure that these products provide consumers with the protections that they expect,” the statement said.
- New sunscreen product labels should be required to make it easier for consumers to identify important information, “including the addition of the active ingredients on the front of the package to bring sunscreen in line with other OTC drugs; a notification on the front label for consumers to read the skin cancer/skin aging alert for sunscreens that have not been shown to help prevent skin cancer; and revised formats for SPF, broad spectrum, and water resistance statements,” the statement said.
- Products that combine sunscreens with insect repellents are not GRASE.
In the meantime, though, consumers should continue to use sunscreens regularly as part of a comprehensive sun protection program, FDA Commissioner Scott Gottlieb, MD, said during the briefing. “Broad spectrum sunscreens with SPF values of at least 15 are critical to the arsenal of tools for preventing skin cancer and protecting the skin from damage caused by the sun’s rays,” he continued. “Given the recognized public health benefits of sunscreen use, Americans should continue to use sunscreens in conjunction with other sun protective measures (such as protective clothing) as this important rule-making effort moves forward.”
To submit comments on this proposed rule, go to https://www.regulations.gov and follow instructions for submitting comments.
including some of those frequently used in over-the-counter products.
The ingredients requiring additional investigation are cinoxate, dioxybenzone, ensulizole, homosalate, meradimate, octinoxate, octisalate, octocrylene, padimate O, sulisobenzone, oxybenzone, and avobenzone. The FDA actions were announced during a press briefing Feb. 21 held to discuss the proposed rule to update regulatory requirements for most sunscreen products marketed in the United States.
There are no urgent safety matters associated with these ingredients. The rule is part of FDA’s charge to construct an over-the-counter (OTC) monograph detailing all available data on sunscreen ingredients, as required by the Sunscreen Innovation Act.
OTC monographs establish conditions under which ingredients may be marketed without approved new drug applications because they are generally recognized as safe and effective (GRASE) “and not misbranded,” according to the FDA. The proposed rule classifies active ingredients and other conditions as Category I (proposed to be GRASE and not misbranded), Category II (proposed to be not GRASE or to be misbranded), or Category III (additional data needed).
“We are proposing that these ingredients require additional data before a positive GRASE determination can be made,” FDA press officer Sandy Walsh said in an interview, referring to the 12 ingredients. “This proposed rule does not represent a conclusion by the FDA that the sunscreen active ingredients proposed as having insufficient data are unsafe for use in sunscreens. Rather, we are requesting additional information on these ingredients so that we can evaluate their GRASE status in light of changed conditions, including substantially increased sunscreen usage and evolving information about the potential risks associated with these products since they were originally evaluated.”
Among its provisions, the proposal addresses sunscreen active-ingredient safety, dosage forms, and sun protection factor (SPF) and broad-spectrum requirements. It also proposes updates to how products are labeled to make it easier for consumers to identify key product information
Thus far, the agency says that only two active ingredients – titanium dioxide and zinc oxide – can be marketed without approved new drug applications because they are GRASE.
However, two other ingredients – PABA and trolamine salicylate – are not GRASE for use in sunscreens because of safety issues, Theresa Michele, MD, director of the Division of Nonprescription Drug Products Division of Nonprescription Drug Products in the FDA’s Center for Drug Evaluation and Research. Products that combine sunscreen and insect repellent also not fit the criteria, she said
“There are 12 ingredients for which there are insufficient safety data to make a positive GRASE determination at this time. To address these 12 ingredients, the FDA is asking industry and other interested parties for additional data. The FDA is working closely with industry and has published several guidances to make sure companies understand what data the agency believes is necessary for the FDA to evaluate safety and effectiveness for sunscreen active ingredients, including the 12 ingredients for which the FDA is seeking more data,” she said.
In addition to seeking these additional data, the rule also proposes the following:
- Dosage forms that are GRASE for use as sunscreens should include sprays, oils, lotions, creams, gels, butters, pastes, ointments, and sticks. While powders are proposed to be eligible for inclusion in the monograph, more data are being requested before powders are included. “Wipes, towelettes, body washes, shampoos, and other dosage forms are proposed to be categorized as new drugs because the FDA has not received data showing they are eligible for inclusion in the monograph,” according to the FDA statement outlining the proposed regulation.
- The maximum proposed SPF value on sunscreen labels should be raised from SPF 50 or higher to SPF 60 or higher. “There are not enough data to suggest that consumers get any extra benefit from products with an SPF of more than 60,” Dr. Michele said.
- Sunscreens with an SPF value of 15 or higher should be required to also provide broad-spectrum protection, and for broad-spectrum products, as SPF increases, the magnitude of protection against UVA radiation should also increase. “These proposals are designed to ensure that these products provide consumers with the protections that they expect,” the statement said.
- New sunscreen product labels should be required to make it easier for consumers to identify important information, “including the addition of the active ingredients on the front of the package to bring sunscreen in line with other OTC drugs; a notification on the front label for consumers to read the skin cancer/skin aging alert for sunscreens that have not been shown to help prevent skin cancer; and revised formats for SPF, broad spectrum, and water resistance statements,” the statement said.
- Products that combine sunscreens with insect repellents are not GRASE.
In the meantime, though, consumers should continue to use sunscreens regularly as part of a comprehensive sun protection program, FDA Commissioner Scott Gottlieb, MD, said during the briefing. “Broad spectrum sunscreens with SPF values of at least 15 are critical to the arsenal of tools for preventing skin cancer and protecting the skin from damage caused by the sun’s rays,” he continued. “Given the recognized public health benefits of sunscreen use, Americans should continue to use sunscreens in conjunction with other sun protective measures (such as protective clothing) as this important rule-making effort moves forward.”
To submit comments on this proposed rule, go to https://www.regulations.gov and follow instructions for submitting comments.
FDA clears first-of-its-kind phone app for insulin management
The Food and Drug Administration has granted 501(k) clearance to a phone app for managing insulin in patients with type 2 diabetes.
The app will enhance Hygieia’s d-Nav Insulin Guidance Service, which uses Cloud-based technology and a small group of health care professionals to support physicians and help patients with diabetes achieve better glycemic control by providing personalized insulin adjustments. The system has been shown, in a 90-day clinical study, to reduce both costs and levels of glycosylated hemoglobin. Patients can use the app to enter glucose-event data and receive a recommended insulin dose.
“Insulin therapy is critical to the health of more than 8 million people in the United States, but it is often ineffective, largely because it requires a continual, personalized adjustment that is not practical for physicians and not manageable for patients. The d-Nav service, including the user-friendly phone app, makes insulin therapy more effective, less time intensive, and less costly for everyone involved,” Eran Bashan, CEO of Hygieia, said in a press release.
This is the first insulin-mangement app that can titrate individualized doses for all insulin regimens and the first that can connect to any glucose meter that shares information with the cloud. It is available for both Android and iOS.
Find the full press release on the Hygieia website.
The Food and Drug Administration has granted 501(k) clearance to a phone app for managing insulin in patients with type 2 diabetes.
The app will enhance Hygieia’s d-Nav Insulin Guidance Service, which uses Cloud-based technology and a small group of health care professionals to support physicians and help patients with diabetes achieve better glycemic control by providing personalized insulin adjustments. The system has been shown, in a 90-day clinical study, to reduce both costs and levels of glycosylated hemoglobin. Patients can use the app to enter glucose-event data and receive a recommended insulin dose.
“Insulin therapy is critical to the health of more than 8 million people in the United States, but it is often ineffective, largely because it requires a continual, personalized adjustment that is not practical for physicians and not manageable for patients. The d-Nav service, including the user-friendly phone app, makes insulin therapy more effective, less time intensive, and less costly for everyone involved,” Eran Bashan, CEO of Hygieia, said in a press release.
This is the first insulin-mangement app that can titrate individualized doses for all insulin regimens and the first that can connect to any glucose meter that shares information with the cloud. It is available for both Android and iOS.
Find the full press release on the Hygieia website.
The Food and Drug Administration has granted 501(k) clearance to a phone app for managing insulin in patients with type 2 diabetes.
The app will enhance Hygieia’s d-Nav Insulin Guidance Service, which uses Cloud-based technology and a small group of health care professionals to support physicians and help patients with diabetes achieve better glycemic control by providing personalized insulin adjustments. The system has been shown, in a 90-day clinical study, to reduce both costs and levels of glycosylated hemoglobin. Patients can use the app to enter glucose-event data and receive a recommended insulin dose.
“Insulin therapy is critical to the health of more than 8 million people in the United States, but it is often ineffective, largely because it requires a continual, personalized adjustment that is not practical for physicians and not manageable for patients. The d-Nav service, including the user-friendly phone app, makes insulin therapy more effective, less time intensive, and less costly for everyone involved,” Eran Bashan, CEO of Hygieia, said in a press release.
This is the first insulin-mangement app that can titrate individualized doses for all insulin regimens and the first that can connect to any glucose meter that shares information with the cloud. It is available for both Android and iOS.
Find the full press release on the Hygieia website.
FDA grants priority review to polatuzumab vedotin for DLBCL
With this BLA, Genentech is seeking approval for polatuzumab vedotin in combination with bendamustine and rituximab (BR) to treat patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).
The FDA grants priority review to applications for products that are expected to provide significant improvements in the treatment, diagnosis, or prevention of serious conditions. The agency aims to take action on a priority review application within 6 months, rather than the standard 10 months.
The FDA is expected to make a decision on this BLA by Aug. 19, 2019.
The BLA is supported by a phase 1b/2 trial (NCT02257567) of patients with relapsed or refractory follicular lymphoma or DLBCL who received polatuzumab vedotin in combination with BR or obinutuzumab.
The trial’s phase 2 stage included 80 DLBCL patients who were randomized to receive BR or BR plus polatuzumab vedotin, according to Genentech.
The complete response rate was 40% in the polatuzumab vedotin arm and 18% in the BR arm. The median duration of response was 10.3 months and 4.1 months, respectively (hazard ratio [HR] = 0.44).
The median progression-free survival was 7.6 months in the polatuzumab vedotin arm and 2.0 months in the BR arm (HR = 0.34).
Among patients who were ineligible for a transplant, the median overall survival (an exploratory endpoint) was 12.4 months in the polatuzumab vedotin arm and 4.7 months in the BR arm (HR = 0.42).
Patients who received polatuzumab vedotin had higher rates of grade 3-4 cytopenias, compared with patients who received BR alone. Rates of infection and transfusion were similar between the arms.
With this BLA, Genentech is seeking approval for polatuzumab vedotin in combination with bendamustine and rituximab (BR) to treat patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).
The FDA grants priority review to applications for products that are expected to provide significant improvements in the treatment, diagnosis, or prevention of serious conditions. The agency aims to take action on a priority review application within 6 months, rather than the standard 10 months.
The FDA is expected to make a decision on this BLA by Aug. 19, 2019.
The BLA is supported by a phase 1b/2 trial (NCT02257567) of patients with relapsed or refractory follicular lymphoma or DLBCL who received polatuzumab vedotin in combination with BR or obinutuzumab.
The trial’s phase 2 stage included 80 DLBCL patients who were randomized to receive BR or BR plus polatuzumab vedotin, according to Genentech.
The complete response rate was 40% in the polatuzumab vedotin arm and 18% in the BR arm. The median duration of response was 10.3 months and 4.1 months, respectively (hazard ratio [HR] = 0.44).
The median progression-free survival was 7.6 months in the polatuzumab vedotin arm and 2.0 months in the BR arm (HR = 0.34).
Among patients who were ineligible for a transplant, the median overall survival (an exploratory endpoint) was 12.4 months in the polatuzumab vedotin arm and 4.7 months in the BR arm (HR = 0.42).
Patients who received polatuzumab vedotin had higher rates of grade 3-4 cytopenias, compared with patients who received BR alone. Rates of infection and transfusion were similar between the arms.
With this BLA, Genentech is seeking approval for polatuzumab vedotin in combination with bendamustine and rituximab (BR) to treat patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).
The FDA grants priority review to applications for products that are expected to provide significant improvements in the treatment, diagnosis, or prevention of serious conditions. The agency aims to take action on a priority review application within 6 months, rather than the standard 10 months.
The FDA is expected to make a decision on this BLA by Aug. 19, 2019.
The BLA is supported by a phase 1b/2 trial (NCT02257567) of patients with relapsed or refractory follicular lymphoma or DLBCL who received polatuzumab vedotin in combination with BR or obinutuzumab.
The trial’s phase 2 stage included 80 DLBCL patients who were randomized to receive BR or BR plus polatuzumab vedotin, according to Genentech.
The complete response rate was 40% in the polatuzumab vedotin arm and 18% in the BR arm. The median duration of response was 10.3 months and 4.1 months, respectively (hazard ratio [HR] = 0.44).
The median progression-free survival was 7.6 months in the polatuzumab vedotin arm and 2.0 months in the BR arm (HR = 0.34).
Among patients who were ineligible for a transplant, the median overall survival (an exploratory endpoint) was 12.4 months in the polatuzumab vedotin arm and 4.7 months in the BR arm (HR = 0.42).
Patients who received polatuzumab vedotin had higher rates of grade 3-4 cytopenias, compared with patients who received BR alone. Rates of infection and transfusion were similar between the arms.
FDA approves turoctocog alfa pegol for hemophilia A
The agency approved turoctocog alfa pegol for use as routine prophylaxis to reduce the frequency of bleeding episodes, for on-demand treatment and control of bleeding episodes, and for perioperative management of bleeding in adults and children with hemophilia A.
Turoctocog alfa pegol will not be available in the United States before 2020, according to Novo Nordisk. The company cannot yet launch the product because of third-party intellectual property agreements.
The FDA’s approval of turoctocog alfa pegol was supported by results from the pathfinder 2 (NCT01480180), pathfinder 3 (NCT01489111), and pathfinder 5 (NCT01731600) trials.
The trials included children, adolescents, and adults with previously treated, severe hemophilia A and no history of inhibitors. Turoctocog alfa pegol was considered effective and well tolerated in these trials.
Pooled results from pathfinder 2 and pathfinder 5 were presented at the 2018 annual meeting of the American Society of Hematology (Blood. 2018:132:1177).
Results from pathfinder 3 were previously published in Haemophilia (2017. Sep;23[5]:689-96).
The agency approved turoctocog alfa pegol for use as routine prophylaxis to reduce the frequency of bleeding episodes, for on-demand treatment and control of bleeding episodes, and for perioperative management of bleeding in adults and children with hemophilia A.
Turoctocog alfa pegol will not be available in the United States before 2020, according to Novo Nordisk. The company cannot yet launch the product because of third-party intellectual property agreements.
The FDA’s approval of turoctocog alfa pegol was supported by results from the pathfinder 2 (NCT01480180), pathfinder 3 (NCT01489111), and pathfinder 5 (NCT01731600) trials.
The trials included children, adolescents, and adults with previously treated, severe hemophilia A and no history of inhibitors. Turoctocog alfa pegol was considered effective and well tolerated in these trials.
Pooled results from pathfinder 2 and pathfinder 5 were presented at the 2018 annual meeting of the American Society of Hematology (Blood. 2018:132:1177).
Results from pathfinder 3 were previously published in Haemophilia (2017. Sep;23[5]:689-96).
The agency approved turoctocog alfa pegol for use as routine prophylaxis to reduce the frequency of bleeding episodes, for on-demand treatment and control of bleeding episodes, and for perioperative management of bleeding in adults and children with hemophilia A.
Turoctocog alfa pegol will not be available in the United States before 2020, according to Novo Nordisk. The company cannot yet launch the product because of third-party intellectual property agreements.
The FDA’s approval of turoctocog alfa pegol was supported by results from the pathfinder 2 (NCT01480180), pathfinder 3 (NCT01489111), and pathfinder 5 (NCT01731600) trials.
The trials included children, adolescents, and adults with previously treated, severe hemophilia A and no history of inhibitors. Turoctocog alfa pegol was considered effective and well tolerated in these trials.
Pooled results from pathfinder 2 and pathfinder 5 were presented at the 2018 annual meeting of the American Society of Hematology (Blood. 2018:132:1177).
Results from pathfinder 3 were previously published in Haemophilia (2017. Sep;23[5]:689-96).
FDA approves pembrolizumab for completely resected melanoma
The Food and Drug Administration has approved pembrolizumab (Keytruda) for the adjuvant treatment of patients with melanoma with lymph node involvement following resection.
FDA approval is based on results from the randomized, double-blind, placebo-controlled EORTC1325/KEYNOTE‑054 trial, in which 1,019 patients with completely resected stage III melanoma received either a placebo or 200 mg of pembrolizumab every 3 weeks for up to 1 year until disease recurrence or unacceptable toxicity.
Recurrence-free survival was significantly better in the pembrolizumab group than in the placebo group (hazard ratio, 0.57; 95% confidence interval, 0.46-0.70; P less than .001). The median recurrence-free survival time was 20.4 months in the placebo group and was not reached in the pembrolizumab group, the FDA said in a press release.
About three-quarters of patients received pembrolizumab for at least 6 months, while 14% of patients had to stop pembrolizumab treatment because of adverse events. The most common adverse events in pembrolizumab-treated patients included diarrhea, pruritus, nausea, arthralgia, hypothyroidism, cough, rash, asthenia, influenzalike illness, weight loss, and hyperthyroidism.
“The recommended pembrolizumab dose and schedule for the adjuvant treatment of melanoma is 200 mg administered as an IV infusion over 30 minutes every 3 weeks until disease recurrence or unacceptable toxicity, for a maximum of 1 year,” the FDA said in the press release.
The Food and Drug Administration has approved pembrolizumab (Keytruda) for the adjuvant treatment of patients with melanoma with lymph node involvement following resection.
FDA approval is based on results from the randomized, double-blind, placebo-controlled EORTC1325/KEYNOTE‑054 trial, in which 1,019 patients with completely resected stage III melanoma received either a placebo or 200 mg of pembrolizumab every 3 weeks for up to 1 year until disease recurrence or unacceptable toxicity.
Recurrence-free survival was significantly better in the pembrolizumab group than in the placebo group (hazard ratio, 0.57; 95% confidence interval, 0.46-0.70; P less than .001). The median recurrence-free survival time was 20.4 months in the placebo group and was not reached in the pembrolizumab group, the FDA said in a press release.
About three-quarters of patients received pembrolizumab for at least 6 months, while 14% of patients had to stop pembrolizumab treatment because of adverse events. The most common adverse events in pembrolizumab-treated patients included diarrhea, pruritus, nausea, arthralgia, hypothyroidism, cough, rash, asthenia, influenzalike illness, weight loss, and hyperthyroidism.
“The recommended pembrolizumab dose and schedule for the adjuvant treatment of melanoma is 200 mg administered as an IV infusion over 30 minutes every 3 weeks until disease recurrence or unacceptable toxicity, for a maximum of 1 year,” the FDA said in the press release.
The Food and Drug Administration has approved pembrolizumab (Keytruda) for the adjuvant treatment of patients with melanoma with lymph node involvement following resection.
FDA approval is based on results from the randomized, double-blind, placebo-controlled EORTC1325/KEYNOTE‑054 trial, in which 1,019 patients with completely resected stage III melanoma received either a placebo or 200 mg of pembrolizumab every 3 weeks for up to 1 year until disease recurrence or unacceptable toxicity.
Recurrence-free survival was significantly better in the pembrolizumab group than in the placebo group (hazard ratio, 0.57; 95% confidence interval, 0.46-0.70; P less than .001). The median recurrence-free survival time was 20.4 months in the placebo group and was not reached in the pembrolizumab group, the FDA said in a press release.
About three-quarters of patients received pembrolizumab for at least 6 months, while 14% of patients had to stop pembrolizumab treatment because of adverse events. The most common adverse events in pembrolizumab-treated patients included diarrhea, pruritus, nausea, arthralgia, hypothyroidism, cough, rash, asthenia, influenzalike illness, weight loss, and hyperthyroidism.
“The recommended pembrolizumab dose and schedule for the adjuvant treatment of melanoma is 200 mg administered as an IV infusion over 30 minutes every 3 weeks until disease recurrence or unacceptable toxicity, for a maximum of 1 year,” the FDA said in the press release.
FDA approves first interoperable insulin infusion pump
, for insulin delivery in children and adults with diabetes.
The pump delivers insulin under the skin at a variable or fixed rate. It can function on its own, or it can be digitally connected to automatically communicate with and receive drug-dosing commands from other diabetes management devices, such as automated insulin-dosing systems, the agency announced.
The approval was based on a review of performance data demonstrating that the device can deliver insulin accurately and reliably and at the rates and volumes programmed by the user. The agency also assessed the pump’s ability to connect reliably with other devices, as well as its cybersecurity and fail-safe modes.
Risks associated with the device were similar to those of other infusion pumps and include infection, bleeding, pain, or skin irritations. Blockages and air bubbles can occur in the tubing, which will affect drug delivery. Risks associated with incorrect drug delivery include hypo- and hyperglycemia as well as diabetic ketoacidosis.
“The marketing authorization of the [pump] has the potential to aid patients who seek more individualized diabetes therapy systems and opens the door for developers of future connected diabetes devices to get other safe and effective products to patients more efficiently,” FDA Commissioner Scott Gottlieb, MD, said in the announcement.
, for insulin delivery in children and adults with diabetes.
The pump delivers insulin under the skin at a variable or fixed rate. It can function on its own, or it can be digitally connected to automatically communicate with and receive drug-dosing commands from other diabetes management devices, such as automated insulin-dosing systems, the agency announced.
The approval was based on a review of performance data demonstrating that the device can deliver insulin accurately and reliably and at the rates and volumes programmed by the user. The agency also assessed the pump’s ability to connect reliably with other devices, as well as its cybersecurity and fail-safe modes.
Risks associated with the device were similar to those of other infusion pumps and include infection, bleeding, pain, or skin irritations. Blockages and air bubbles can occur in the tubing, which will affect drug delivery. Risks associated with incorrect drug delivery include hypo- and hyperglycemia as well as diabetic ketoacidosis.
“The marketing authorization of the [pump] has the potential to aid patients who seek more individualized diabetes therapy systems and opens the door for developers of future connected diabetes devices to get other safe and effective products to patients more efficiently,” FDA Commissioner Scott Gottlieb, MD, said in the announcement.
, for insulin delivery in children and adults with diabetes.
The pump delivers insulin under the skin at a variable or fixed rate. It can function on its own, or it can be digitally connected to automatically communicate with and receive drug-dosing commands from other diabetes management devices, such as automated insulin-dosing systems, the agency announced.
The approval was based on a review of performance data demonstrating that the device can deliver insulin accurately and reliably and at the rates and volumes programmed by the user. The agency also assessed the pump’s ability to connect reliably with other devices, as well as its cybersecurity and fail-safe modes.
Risks associated with the device were similar to those of other infusion pumps and include infection, bleeding, pain, or skin irritations. Blockages and air bubbles can occur in the tubing, which will affect drug delivery. Risks associated with incorrect drug delivery include hypo- and hyperglycemia as well as diabetic ketoacidosis.
“The marketing authorization of the [pump] has the potential to aid patients who seek more individualized diabetes therapy systems and opens the door for developers of future connected diabetes devices to get other safe and effective products to patients more efficiently,” FDA Commissioner Scott Gottlieb, MD, said in the announcement.