FDA: Mineral oil unlikely culprit in REDUCE-IT outcome

FDA sliced and diced the CVOT data for Amarin’s Vascepa and found little reason to think the mineral oil control arm may have confounded the positive outcome. Now, the agency is asking its Endocrinologic and Metabolic Drugs Advisory Committee to weigh in on the analyses as well as a handful of new safety signals to determine if the triglyceride-lowering drug should get an expanded cardioprotective indication.

Shares of Amarin Corp. plc (NASDAQ:AMRN) were up $4.03 (24%) Tuesday to $20.94, giving the company a market cap of about $7.5 billion...