BioCentury
ARTICLE | Company News

Still no decision from FDA on Amarin's Vascepa SPA

January 16, 2014 12:47 AM UTC

Amarin Corp. plc (NASDAQ:AMRN) said FDA notified the company that the agency will not make a decision on Amarin's request to reinstate an SPA for the Phase III ANCHOR trial by Wednesday -- when the agency had previously said it expected to have a decision on the request. Amarin is seeking to expand the label of its hypertriglyceridemia drug Vascepa icosapent ethyl based on data from the 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 Amarin said FDA -- which rescinded the SPA in October -- did not provide a new "definitive date" for a decision.

Last month, FDA delayed a decision on the sNDA for Vascepa and 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 (see BioCentury Extra, Dec. 20, 2013). ...