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Tuesday, March 30, 2021

Amarin Wins EU Approval For Icosapent Ethyl

 

  • The European Commission (EC) has approved the marketing authorization application for Amarin Corporation Plc's (NASDAQ: AMRN) Vazkepa (icosapent ethyl) for cardiovascular risk reduction.

  • The approval covers reducing the risk of cardiovascular events in high-risk, statin-treated adult patients who have elevated triglycerides and either established cardiovascular disease or diabetes and at least one additional cardiovascular risk factor.

  • Amarin's icosapent ethyl was approved for cardiovascular risk reduction by the FDA in December 2019 and marketed in the U.S. under the brand name, Vascepa.

  • Yesterday, Amarin's Canadian partner, HLS Therapeutics Inc, announced the Canadian Cardiovascular Society recommended using icosapent ethyl to lower the risk of cardiovascular events.

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