Advisory Committee Supports Amarin’s Vascepa for Cardiovascular Events

An FDA advisory committee voted unanimously to recommend approval of Amarin Pharmaceuticals’ Vascepa (icosapent ethyl) to reduce the risk of cardiovascular events in adults.

The Endocrinologic and Metabolic Drugs Advisory Committee previously turned down expanding the drug’s indication in 2013 because of the lack of supporting data.

This time around, the committee unanimously agreed that the company provided sufficient evidence that the drug reduced the risk of cardiovascular events in conjunction with statin therapy in adults with elevated triglyceride levels.