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Stock impact report

FDA to Review Supplemental Biologics License Application for Praluent® (alirocumab)Injection as Potential Treatment to Reduce Major Adverse Cardiovascular Events

Regeneron Pharmaceuticals, Inc. (REGN) 
Last regeneron pharmaceuticals, inc. earnings: 2/6 06:30 am Check Earnings Report
US:NASDAQ Investor Relations: investor.regeneron.com
Company Research Source: PR Newswire
TARRYTOWN, N.Y. and PARIS, Sept. 12, 2018 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi announced that the U.S. Food and Drug Administration (FDA) has accepted a supplemental Biologics License Application (sBLA) for Praluent® (alirocumab) Injection, a PCSK9 inhibitor. The sBLA outlines a proposed update to the Prescribing Information to include the effect of Praluent in reducing the overall risk of major adverse cardiovascular events (MACE). MACE is an umbrella term that includes heart attack, ischemic stroke, death from coronary heart disease and unstable angina requiring hospitalization. The FDA set a Prescription Drug User Fee Act (PDUFA) action date of April 28, 2019.The sBLA is supported by data from ODYSSEY OUTCOMES, a Phase 3 cardiovascular outcomes trial that assessed the effect of Praluent in 18,924 patients who had an acute coronary syndrome (ACS), such as a heart attack, between 1-12 months (median 2.6 months) before enrolling in the trial. Re Show less Read more
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