BioCentury
ARTICLE | Clinical News

FDA says Amarin's ANCHOR endpoint no longer sufficient

October 30, 2013 12:53 AM UTC

Amarin Corp. plc (NASDAQ:AMRN) fell 15% in early after-hours trading after the company disclosed in an SEC filing late Tuesday that FDA said it no longer considers a change in serum triglyceride levels sufficient to "establish the effectiveness" of a drug for reducing cardiovascular risk in patients with triglyceride levels less than 500 mg/dL. The agency revoked an SPA for Amarin's Phase III ANCHOR trial, which evaluated Vascepa icosapent ethyl 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. In 2011, Amarin said Vascepa met the primary endpoint in ANCHOR of reducing triglycerides from baseline to week 12 vs. placebo.

Amarin is seeking approval for the indication based on the data. Earlier this month, FDA's Endocrinologic and Metabolic Drugs Advisory Committee voted 9-2 against expanding Vascepa's label to include the indication prior to the completion of Amarin's REDUCE-IT cardiovascular outcomes trial. The primary endpoint of REDUCE-IT is a composite of cardiovascular death, myocardial infarction, stroke, coronary revascularization and hospitalization for unstable angina. Data from the trial are not expected until at least 2016. The sNDA for Vascepa has a Dec. 20 PDUFA date (see BioCentury Extra, Oct. 16). ...