Thursday bodes well for Amarin

It appears as though Amarin’s fish oil-based heart drug, Vascepa, could be on its way toward winning expanded approval. That, anyway, seems to be the likely outcome based on FDA documents that are expected to be the basis of the agency's advisory committee on the drug on Thursday.

Amarin is seeking to expand Vascepa’s label to include data that it may reduce risk of heart attacks, stroke, and death by 25%. That’s pretty significant, since no existing triglyceride treatment has been shown to reduce the incidence of these adverse events.

The FDA review did find some flaws in the recent Vascepa cardiovascular outcomes trial, but none seems significant enough to bode ill for the company, STAT’s Matthew Herper and Adam Feuerstein write.