FDA panel rebuffs Amarin's Vascepa

FDA's Endocrinologic and Metabolic Drugs Advisory Committee voted 9-2 on Wednesday against expanding the label of Vascepa icosapent ethyl from Amarin Corp. plc (NASDAQ:AMRN) to include treatment of patients with mixed dyslipidemia in combination with statins prior to the completion of Amarin's REDUCE-IT cardiovascular outcomes trial. Data from REDUCE-IT are not expected until at least 2016.

Amarin is seeking approval for Vascepa to treat high triglycerides -- defined as triglyceride levels 200 mg/dL or greater and less than 500 mg/dL -- in patients with mixed dyslipidemia and congenital heart disease (CHD) or CHD risk equivalents. The company defines CHD risk equivalents as comprising other clinical forms of atherosclerotic disease, diabetes or multiple risk factors that confer a 10-year risk for CHD greater than 20%. The sNDA has a Dec. 20 PDUFA date. ...