Sanofi

FDA approves Praluent (alirocumab) to prevent heart attack, stroke and unstable angina requiring hospitalization

FDA approves Praluent (alirocumab) to prevent heart attack, stroke and unstable angina requiring hospitalization

• Praluent is the first PCSK9 inhibitor that has shown a meaningful reduction in death from any cause
• Praluent treatment effect was observed in patients already receiving other lipid-lowering therapies, including maximally-tolerated statins

PARIS and TARRYTOWN, NY - April 26, 2019 - The U.S. Food and Drug Administration (FDA) has approved Praluent (alirocumab) to reduce the risk of heart attack, stroke, and unstable angina requiring hospitalization in adults with established cardiovascular (CV) disease.

"Today's FDA approval marks a significant achievement in the treatment of adults with established cardiovascular disease, who are among those at greatest risk of death or disability caused by serious cardiovascular events," said John Reed, M.D., Ph.D., Global Head of Research & Development, Sanofi. "Praluent has already helped many adults lower their LDL-C levels, and this new indication provides an opportunity to help appropriate patients by reducing the risk of serious, life-threatening cardiovascular events, including heart attacks and stroke."

High levels of "bad" cholesterol, also known as low-density lipoprotein cholesterol (LDL-C), increase patients' risk for serious CV events such as heart attack or stroke. Adults who experience a heart attack or stroke have an approximately one in three chance to have another CV event.

"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."