Amarin’s Vascepa Nabs Expanded FDA Approval

The FDA approved an expanded label for Amarin Pharmaceuticals’ Vascepa (icosapent ethyl) as an adjunctive therapy to reduce the risk of cardiovascular events among adults with elevated triglyceride levels.

Vascepa was initially approved in 2012 for adults with high triglyceride levels and the supplemental NDA for this indication received priority review. The approval makes Vascepa the first FDA approved drug to reduce cardiovascular risk among patients with elevated triglyceride levels as an add-on to statin therapy.

The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee unanimously voted to expand the drug’s label last month after previously turning it down.