FDA Approves Praluent® (Alirocumab) to Prevent Heart Attack, Stroke and Unstable Angina Requiring Hospitalization

Regeneron Pharmaceuticals, Inc. and Sanofi have announced that the U.S. Food and Drug Administraion (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.  

The FDA approval is based on data from ODYSSEY OUTCOMES, which was published in the New England Journal of Medicine in November 2018, assessing the effect of adding Praluent to maximally-tolerated statins on CV outcomes in 18,924 patients who had an acute coronary syndrome (ACS) within a year of enrolling in the trial.

The FDA also approved Praluent as an adjunct to diet, alone or in combination with other lipid-lowering therapies (e.g., statins, ezetimibe), for the treatment of adults with primary hyperlipidemia (including heterozygous familial hypercholesterolemia) to reduce LDL-C.

To read the full press release announcing the FDA decision, click here: https://investor.regeneron.com/news-releases/news-release-details/fda-approves-praluentr-alirocumab-prevent-heart-attack-stroke or here: http://hugin.info/152918/R/2242799/885333.pdf