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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.
Price Action: AMRN shares are up 4.6% at $6.41 in premarket trading on the last check Tuesday.
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