FDA advisory panel goes negative on Amarin’s Vascepa

US biotech firm Amarin (Nasdaq: AMRN) revealed yesterday (October16) that the US Food and Drug Administration Endocrinologic and Metabolic Drugs Advisory Committee has voted nine to two against approval of the firm’s Vascepa (icosapent ethyl) capsules.

The opinion dealt a major blow to Amarin, with advisors saying that the government should delay expanding approval of Amarin’s proposed prescription fish-oil drug until more patient data is available. The advisory panel indicated that the ongoing REDUCE-IT cardiovascular outcomes study should be completed before widening approval of Vascepa.

Vascepa was being reviewed for use as an adjunct to diet and exercise and in combination with a statin in the treatment of adult patients with high triglycerides (TG 200-499mg/dL) with mixed dyslipidemia and coronary heart disease (CHD) or a CHD risk equivalent (the ANCHOR indication) based on the information presented at the committee meeting yesterday.