Posted by Michael Wonder on 28 Apr 2019
FDA approves Praluent (alirocumab) to prevent heart attack, stroke and unstable angina requiring hospitalisation
26 April 2019 - Praluent is the first PCSK9 inhibitor that has shown a meaningful reduction in death from any cause.
Regeneron Pharmaceuticals and Sanofi today announced that the U.S. FDA has approved Praluent (alirocumab) to reduce the risk of heart attack, stroke and unstable angina requiring hospitalisation in adults with established cardiovascular (CV) disease.
"Heart disease accounts for one quarter of all American deaths each year and many others are at risk for heart attack and stroke due to uncontrolled LDL-C levels," said George D. Yancopoulos, M.D., Ph.D., President and Chief Scientific Officer, Regeneron. "The Phase 3 ODYSSEY OUTCOMES trial showed that people who received Praluent significantly reduced their risk for serious cardiovascular events. There was also a clinically-meaningful reduction in death from any cause with Praluent treatment. With this approval, and the recent introduction of a lower U.S. Praluent list price, we hope that more patients in need will be able to access Praluent."
