Amarin: CHMP Nod for Icosapent Ethyl for Cardiovascular Risk

 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

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.

https://www.globenewswire.com/news-release/2021/01/29/2166794/0/en/Amarin-Receives-Positive-CHMP-Opinion-for-Icosapent-Ethyl-for-Cardiovascular-Risk-Reduction.html