Phase III data for Amarin's Vascepa link triglycerides to CV risk

Amarin Corp. plc. (NASDAQ:AMRN) reported top-line data from the Phase III REDUCE-IT trial showing that once-daily 4 g Vascepa icosapent ethyl led to a 25% reduction in major adverse cardiovascular events (MACE) vs. placebo, meeting the primary endpoint (p<0.001). Vascepa is an ethyl ester of eicosapentaenoic acid (ethyl-EPA).

A lack of definitive data relating triglyceride lowering to CV protection has prevented physicians from prescribing Vascepa to at-risk patients, but Amarin hopes the REDUCE-IT data will remove physicians' hesitations. Additional data will be presented Nov. 10 at the American Heart Association meeting in Chicago, and the company expects to submit an sNDA to FDA early next year...