Drugs

Panel Backs Expanded Vascepa Use

FDA’s Endocrinologic and Metabolic Diseases Advisory Committee has voted 16 to 0 to recommend approval for Amarin’s submission to expand Vascepa’s (icosapent ethyl) indication to reduce the risk of cardiovascular events as an adjunct to statin therapy in adults with elevated triglycerides and other cardiovascular disease risk factors. The positive vote came on the basis of data from the REDUCE-IT trial and despite FDA highlighting two new safety signals that were not seen before. A briefing document says that more patients treated with Vascepa in the REDUCE-IT trial experienced atrial fibrillation or atrial flutter requiring hospitalization. And more patients treated with the drug also experienced a bleeding event such as gastrointestinal bleeding or contusions.

FDA reviewers noted that Vascepa treatment led to a 25% reduction in heart risks compared to placebo. However, they said, questions have remained about whether use of a mineral oil placebo inflated the drug’s reported benefit. The reviewers indicated they were not able to conclusively prove that hypothesis and said that in any case the impact of raised LDL levels would not have been sufficient to significantly change the clinical trial results.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome