CHMP recommends approval of Vazkepa for the risk of cardiovascular events.- Amarin Corp

Amarin Corporation 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.Thee 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.>