FDA panel backs Vascepa CV indication, mixed on broad label

An FDA panel Thursday unanimously supported an expanded label for Amarin's Vascepa to include reduction of cardiovascular risks but could not agree on what population of patients should get the drug.

FDA's Endocrinologic and Metabolic Drugs Advisory Committee voted 16-0 that Amarin Corp. plc (NASDAQ:AMRN) provided sufficient data to support approval of Vascepa icosapent ethyl to reduce the risk of cardiovascular events as an adjunct to statin therapy in adult patients with elevated triglyceride levels and other risk factors for cardiovascular disease. ...