BioCentury
ARTICLE | Company News

FDA says no decision yet for Amarin's Vascepa

December 21, 2013 2:24 AM UTC

Amarin Corp. plc (NASDAQ:AMRN) said FDA notified the company that the agency will not make a decision on an sNDA seeking to expand the label of hypertriglyceridemia drug Vascepa icosapent ethyl by the Friday PDUFA date. The company is seeking to expand Vascepa's label based on data from the Phase III ANCHOR trial, which evaluated Vascepa in combination with statins to treat high triglycerides -- defined as triglyceride levels 200 mg/dL or greater and less than 500 mg/dL -- in patients with mixed dyslipidemia. Amarin said FDA did not assign the application a new PDUFA date. Vascepa is already approved in the U.S. as an adjunct to diet to reduce triglyceride levels in adults with severe hypertriglyceridemia, defined as triglyceride levels of greater than 500 mg/dL.

According to Amarin, FDA attributed the lack of action on the sNDA to Amarin's request to reinstate an SPA for the ANCHOR trial, which the agency said "remains under consideration." FDA revoked the SPA in October. The agency said it expects to complete its review of Amarin's request by Jan. 15 (see BioCentury Extra, Oct. 29). ...