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Positive opinion is based on extensive clinical study results, including results of the REDUCE-IT® cardiovascular outcomes study
European Commission decision on the Marketing Authorisation Application expected in April 2021
DUBLIN, Ireland and BRIDGEWATER, N.J., Jan. 29, 2021 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN) today 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.
“We thank the EMA for its thoughtful review of our application and concluding it in a timely manner despite the challenges imposed by COVID-19,” said Steven Ketchum, senior vice president, president of R&D and chief scientific officer of Amarin. “This positive CHMP opinion is a significant milestone for Amarin, taking us one step closer to making this important therapy available to millions of patients in the European Union at high risk of cardiovascular events such as heart attacks and strokes. We are dedicated to supporting a rethinking of cardiovascular disease risk reduction in Europe with further emphasis on preventative care.”
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
