Amarin now says FDA plans outside panel review of its Vascepa heart drug, delaying approval decision
Remember when Amarin (AMRN) said, a little more than one week ago, that the Food and Drug Administration was “unlikely” to convene an advisory committee meeting to review data on an expanded use of its heart drug Vascepa?
Wrong. On Thursday, Amarin reversed course, announcing that, indeed, the FDA has scheduled a Vascepa advisory committee meeting for Nov. 14. The agency’s deadline for making an approval decision on the heart drug will also likely be extended into late December from Sept. 28, the company said.
