Despite FDA's concerns, advisory committee unanimously endorses Vascepa's labeling expansion, with 10 of 16 members also favoring approval for secondary as well as primary prevention even as several voiced misgivings about efficacy in the REDUCE-IT trial's lower risk cohort.
A US Food and Drug Administration advisory committee on 14 November unanimously endorsed Amarin Corp. PLC’s Vascepa (icosapant ethyl) for a broad cardiovascular risk reduction claim despite many panelists’ reservations about the strength of the efficacy data for primary prevention in patients that do not have established CV disease.
Ten of 16 members of the Endocrinologic and Metabolic Drugs Advisory Committee favored approval for an indication encompassing secondary prevention...
A real-world evidence study also does not meet the regulatory standard for an adequate and well-controlled clinical investigation, the agency said. The FDA should allow the accelerated approval drug to remain available like other treatments that failed their confirmatory trials, Intercept said.
Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.
New marketing authorization applications filed with the European Medicines Agency's human medicines committee (the CHMP) for review under the EU's centralized procedure. Updated monthly.
Proposal to have panelists rate the strength of efficacy and safety evidence on a numeric scale also draws support in written comments on ways to optimize the advisory committee process.
A real-world evidence study also does not meet the regulatory standard for an adequate and well-controlled clinical investigation, the agency said. The FDA should allow the accelerated approval drug to remain available like other treatments that failed their confirmatory trials, Intercept said.
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Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.
