Posted by Michael Wonder on 12 Sep 2018
FDA to review supplemental biologics license application for Praluent (alirocumab) injection as potential treatment to reduce major adverse cardiovascular events
12 September 2018 - FDA also recently approved Praluent label update for some patients currently requiring LDL apheresis therapy.
Sanofi and Regeneron Pharmaceuticals announced that the U.S. FDA has accepted a supplemental biologics license application for Praluent (alirocumab) Injection, a PCSK9 inhibitor. The application 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, ischaemic stroke, death from coronary heart disease and unstable angina requiring hospitalisation. The FDA set a Prescription Drug User Fee Act action date of 28 April 2019.
The application 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, such as a heart attack, between 1-12 months (median 2.6 months) before enrolling in the trial.
