ARTICLE | Clinical News

Vascepa icosapent ethyl regulatory update

January 20, 2014 8:00 AM UTC

Amarin 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 Jan. 15 - the date 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 and <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 Amarin said FDA - which rescinded the SPA in October - did not provide a new "definitive date" for a decision. ...