Regeneron Pharmaceuticals and Sanofi have secured FDA approval for Praluent (alirocumab) to reduce the risk of heart attack, stroke and unstable angina requiring hospitalisation in adults with established cardiovascular (CV) disease.
The approval is based on data from ODYSSEY OUTCOMES, which was published in the New England Journal of Medicine and assessed 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 Phase 3 ODYSSEY OUTCOMES trial showed that people who received Praluent significantly reduced their risk for serious cardiovascular events,” said George D. Yancopoulos, President and Chief Scientific Officer of Regeneron.
“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.”
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 low-density lipoprotein cholesterol.
Praluent was the first PCSK9 (proprotein convertase subtilisin/kexin type 9) inhibitor approved by the FDA and is the only PCSK9 inhibitor available in two doses with two levels of efficacy as a single 1 mL injection (75 mg and 150 mg) once every two weeks.