Amarin Corporation plc announced that in response to Amarin’s Marketing Authorisation Application submission, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending that a marketing authorisation be granted to icosapent ethyl in the European Union for the reduction of risk of cardiovascular events in patients at high cardiovascular risk, under the brand name VAZKEPA®. The CHMP recommendation is now expected to be reviewed by the European Commission, which has the authority to approve medicines for marketing in the European Union. A decision by the European Commission is expected to take place within 67 days of the CHMP opinion. The CHMP opinion is based on over a decade of development and testing of icosapent ethyl, including data from the REDUCE-IT® cardiovascular outcomes study. REDUCE-IT evaluated more than 8,000 high risk patients who despite having their cholesterol levels well controlled by statin therapy remained at significant risk of heart attack, stroke, or other major adverse cardiovascular events (MACE), including death. As published, patients in the REDUCE-IT study had a median follow-up period of nearly five years. Results from this study, in which all patients remained treated by statins (and by other contemporary therapies) and where half the patients received icosapent ethyl and the other half received placebo, demonstrated a 25% relative risk reduction (p<0.001) in the first occurrence of MACE in the intent-to-treat patient population with use of icosapent ethyl (4 grams daily) compared with placebo. Based on communications with the EMA it expect the indication language to be generally consistent with the following: That marketing authorisation be granted to icosapent ethyl to reduce the risk of cardiovascular events in adult statin-treated patients at high cardiovascular risk with elevated triglycerides (=150 mg/dL), and established cardiovascular disease, or diabetes, and at least one other cardiovascular risk factor. Ten years of market protection is expected to be granted in the European Union as part of a European Commission approval of the pending application. In addition, pending patent applications related to the REDUCE-IT study have the potential to extend exclusivity in Europe into 2039.