FDA accepts sBLA for Praluent to reduce CV events.-Regeneron

Sanofi and Regeneron Pharmaceuticals, Inc. announced that the 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 III 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. Results of the ODYSSEY OUTCOMES trial were presented at the American College of Cardiology's 67th Annual Scientific Session & Expo in March 2018.