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Sanofi: FDA Approves Praluent To Prevent Heart Attack, Stroke, Unstable Angina

French drug giant Sanofi SA (SNYNF,SNY) announced that the U.S. Food and Drug Administration has approved Praluent (alirocumab) to reduce the risk of heart attack, stroke, and unstable angina requiring hospitalization in adults with established cardiovascular or CV disease.

Praluent was developed by Sanofi and biotechnology company Regeneron (REGN) under a global collaboration agreement.

The FDA also approved Praluent as an adjunct to diet, alone or in combination with other lipid-lowering therapies, such as statins, ezetimibe, for the treatment of adults with primary hyperlipidemia to reduce LDL-C.

George Yancopoulos, President and Chief Scientific Officer, Regeneron, said, "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."

Praluent is approved in more than 60 countries around the world.

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