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Amarin Heads Into Vascepa Expansion Labeling Talks After Positive US FDA Panel Review

 
• By Sue Sutter

Focus of negotiations with agency will be on breadth of population encompassed by a cardiovascular risk reduction indication; most advisory committee members favored a broad claim for secondary and primary prevention reflecting the REDUCE-IT trial population, but some strongly opposed an indication that includes patients without established CV disease.

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A US FDA panel gave a unanimous thumbs up to expanding Vascepa's label • Source: Shutterstock

Amarin Corp. PLC could be facing extensive labeling negotiations with the US Food and Drug Administration given that an advisory committee's strong endorsement of a cardiovascular risk reduction claim for Vascepa (icosapant ethyl) came with misgivings about the appropriate target population for the triglyceride-lowering drug.

On 14 November, the Endocrinologic and Metabolic Drugs Advisory Committee unanimously recommended approval of Vascepa to reduce the risk of CV events based on the results of the 8,179-patient REDUCE-IT outcomes trial

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