ARTICLE | Clinical News

Vascepa icosapent ethyl regulatory update

September 22, 2014 7:00 AM UTC

Amarin said FDA's Office of New Drugs denied Amarin's appeal of FDA's rescission of the SPA for the Phase III ANCHOR trial evaluating Vascepa icosapent ethyl in combination with statins to treat high triglycerides. In a May SEC filing, Amarin said FDA upheld the October recession after the company filed an appeal in January. Amarin subsequently appealed to the next level within FDA. Amarin said it is evaluating FDA's response and potential next steps.

Last October, Amarin said the agency said it no longer considers ANCHOR's primary endpoint -- change in serum triglyceride levels -- sufficient to "establish the effectiveness" of a drug for reducing cardiovascular risk in patients with triglyceride levels of <500 mg/dL. An sNDA for the drug based on the data was under review at the time of the rescission. Amarin said it has not yet received a decision on the application. ...