The Food and Drug Administration (FDA) has approved Praluent (alirocumab; Sanofi and Regeneron), a proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitor, to reduce the risk of myocardial infarction (MI), stroke, and unstable angina requiring hospitalization in adults with established cardiovascular disease.

The approval was based on data from the ODYSSEY OUTCOMES trial, a double-blind, placebo-controlled study conducted in 18,924 patients who had experienced an acute coronary syndrome (ACS) in the previous 12 months. The primary outcome measure of the study was a composite of death from coronary heart disease, nonfatal MI, fatal or nonfatal ischemic stroke, or unstable angina requiring hospitalization.

Results showed that the overall risk of major cardiovascular events (MACE) was reduced by 15% in patients who received Praluent with maximally-tolerated statins compared with those who remained on statins alone (hazard ratio [HR] 0.85, CI: 0.78, 0.93, P =.0003).

“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,” said George D. Yancopoulos, MD, PhD, President and Chief Scientific Officer, Regeneron. “With this approval, and the recent introduction of a lower US Praluent list price, we hope that more patients in need will be able to access Praluent.”

In addition, the FDA has 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 low-density lipoprotein cholesterol (LDL-C).

Alirocumab Approved to Reduce Risk for Serious Cardiovascular Events

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