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Friday, December 13, 2019

FDA OKs CV benefit claim for Amarin’s Vascepa

As expected, the FDA approves a cardiovascular (CV) benefit claim for Amarin’s (NASDAQ:AMRN) Vascepa (icosapent ethyl) based on results from the large-scale REDUCE-IT study.
The approved use is as an adjunct therapy to reduce the risk of CV events in adults with elevated triglyceride levels of 150 milligrams per deciliter or higher. Patients must also have either established cardiovascular disease or diabetes and two or more additional risk factors for cardiovascular disease.
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