Heading into a pivotal advisory committee meeting for Amarin Corp. PLC’s Vascepa (icosapant ethyl), the US Food and Drug Administration is questioning whether the REDUCE-IT cardiovascular outcomes trial results support the breadth of the CV risk reduction indication sought by the sponsor.
Amarin’s Vascepa: US FDA Panel To Scrutinize Breadth Of CV Risk Reduction
REDUCE-IT enrolled a higher risk group than the broad population targeted by Amarin’s proposed indication statement, agency says; although reviewers conclude an interaction between the mineral oil placebo and statins cannot be excluded, any impact would have been small and unlikely to change overall treatment effect.
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