FDA rejects expanded use of Amarin's Vascepa

Shares of Amarin tumbled about 10% on 28 April after the company disclosed the FDA declined to expand the use of Vascepa (icosapent ethyl) in the US as an adjunct to diet to reduce triglyceride (TG) levels in adults on statin therapy with mixed dyslipidemia and TG levels from 200mg/dL to 499mg/dL – the so-called ANCHOR indication.

Vascepa, a semisynthetic, 96% ultra-pure ethyl ester of eicosapentaenoic acid, already is approved in the US as an adjunct to diet to reduce TG levels in adults