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Amarin’s Vascepa Positioned For Broad CV Risk Reduction Claim Following US FDA Panel Nod

 
• By Sue Sutter

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.

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US FDA's external advisors voted 16-0 to expand Vascepa's label.

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 in patients with existing CV disease and primary prevention in...

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