FDA declines to reinstate Vascepa SPA

Amarin Corp. plc (NASDAQ:AMRN) fell $0.54 (24%) to $1.73 on Tuesday after FDA's Division of Metabolism and Endocrinology Products said it "does not plan to re-instate" an SPA for the company's Phase III ANCHOR trial. Amarin is seeking to expand the label of its hypertriglyceridemia drug Vascepa icosapent ethyl based on 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. The drug 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).

According to Amarin, FDA -- which revoked the SPA in October -- reiterated its position that available data from other studies do not support the use of reductions in serum triglyceride levels as a basis for approval of a drug for reducing cardiovascular risk. In 2011, Amarin said Vascepa met the primary endpoint in ANCHOR of reducing triglycerides from baseline to week 12 vs. placebo (see BioCentury Extra, Oct. 29, 2013). ...