The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted a Marketing Authorization for Vazkepa (icosapent ethyl), according to Ireland-incorporated Amarin Corp (Nasdaq: AMRN), whose New York-listed shares closed up 2% at $5.19 on Thursday.
Vazkepa is cleared as a treatment to reduce the risk of cardiovascular events in high cardiovascular risk statin-treated adult patients who have elevated triglycerides (≥150 mg/dL) and either established cardiovascular disease or diabetes, and at least one additional cardiovascular risk factor.
The MHRA’s license swiftly follows the European Medicine Agency advisory committee, CHMP, recommending authorization for icosapent ethyl on March 30, 2021. Approved to reduce triglycerides since 2012, icosapent ethyl, under the trade name Vascepa, was cleared in the USA as an adjunctive therapy to reduce the risk of cardiovascular events in late 2019.
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