With a key approval decision less than two months away, Amarin said Wednesday that the Food and Drug Administration is “unlikely” to convene an advisory committee meeting to review data on an expanded use of its heart drug Vascepa.
Amarin’s statement, offered as an update with its second-quarter earnings announcement, was meant to quell any residual investor concerns about the FDA’s ongoing review of Vascepa — with a decision deadline of Sept. 28.
No FDA advisory committee meeting is good news for the Vascepa review.
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Adam, can you supply the citation for the study showing ” 25% reduction in the risk of bad cardiovascular events like heart attacks and strokes” with Vascepa treatment? Thanks!