Amarin falls after FDA reviewers cautious on Vascepa expansion

Amarin Corp. plc (NASDAQ:AMRN) fell $1.28 (20%) to $5.09 on Friday after FDA reviewers questioned whether the agency should approve hypertriglyceridemia drug Vascepa icosapent ethyl for a broader population without cardiovascular data showing a benefit. The reviewers said FDA "has historically considered granting approval for lipid-altering drugs based on favorable changes in the lipid profile, with the assumption that these changes would translate into a benefit on clinical outcomes." However, the reviewers noted that recent cardiovascular outcome trials "have failed to demonstrate a reduction in residual cardiovascular risk with non-statin lipid-altering treatment, despite improving parameters such as HDL-C." The details came in briefing documents released ahead of an Oct. 16 meeting of FDA's Endocrinologic and Metabolic Drugs Advisory Committee to discuss an sNDA for Vascepa, which has a Dec. 20 PDUFA date. Data from Amarin's REDUCE-IT cardiovascular outcomes trials of Vascepa are not expected until at least 2016. ...