Vascepa icosapent ethyl regulatory update

Amarin submitted an sNDA to FDA for Vascepa icosapent ethyl as an adjunct to diet to treat adult patients with high triglycerides, defined as triglyceride levels of >=200 mg/dL and <500 mg/dL, with mixed dyslipidemia. The >96% pure ethyl ester of eicosapentaenoic acid (ethyl-EPA) is already marketed in the U.S. as an adjunct to diet to reduce triglyceride levels in adults with severe hypertriglyceridemia, defined as triglyceride levels of >=500 mg/dL (see BioCentury, Feb. 4). ...