FDA approval of Praluent ® to prevent heart attack, stroke & unstable angina

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The FDA approval of Praluent ® (alirocumab) to reduce the risk of heart attack, stroke, and unstable angina requiring hospitalisation. 

The U.S. Food and Drug Administration has approved Praluent® (alirocumab) to reduce the risk of heart attack, stroke, and unstable angina in adult patients with established cardiovascular (CV) disease.

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.

The FDA approval of Praluent 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. Patients who received Praluent in the trial experienced:

  • A 15% reduced risk for major CV events. The primary endpoint included time to first heart attack, stroke, death from coronary heart disease (CHD), or unstable angina requiring hospitalisation.
  • A 27% reduced risk of stroke, 14% reduced risk of non-fatal heart attack and 39% reduced risk of unstable angina requiring hospitalisation.
  • A 15% reduced risk of death from any cause was also observed.

The FDA approval of Praluent also includes approval of 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.

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.

Praluent® (alirocumab) inhibits the binding of PCSK9 to the LDL receptor and thereby increases the number of available LDL receptors on the surface of liver cells to clear LDL, which lowers LDL-C levels in the blood. Praluent was developed by Regeneron and Sanofi under a global collaboration agreement.

In March 2019 the European Commission approved Praluent ® to reduce risk in ASCVD patients

John Reed, M.D., Ph.D., Global Head of Research & Development, Sanofi said, “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. Praluent has 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.”

George D. Yancopoulos, M.D., Ph.D., President and Chief Scientific Officer, Regeneron said, “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. 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.”