High low-density lipoprotein cholesterol (LDL-C) levels are known to increase the risk for serious cardiovascular (CV) events such as heart attack and stroke. Credit: Bryan Brandenburg.

Regeneron Pharmaceuticals and Sanofi’s Praluent (alirocumab) has received US Food and Drug Administration (FDA) approval.

The drug is designed to mitigate the risk of heart attack, stroke and unstable angina in adults with cardiovascular (CV) disease. It blocks proprotein convertase subtilisin / kexin type 9 (PCSK9) from binding with low-density lipoprotein (LDL) receptors, which causes more LDL receptors to form on the surface of liver cells and lowers LDL cholesterol (LDL-C) levels in the blood.

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High LDL-C levels are known to increase the risk for serious CV events such as heart attack and stroke.

The drug was invented by Regeneron, which worked with Sanofi as part of a global collaboration agreement.

“This new indication provides an opportunity to help appropriate patients by reducing the risk of serious, life-threatening cardiovascular events.”

Praluent is approved by the FDA as an adjunct to dieting, for use as the sole treatment, or in combination with other lipid-lowering therapies for adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia.

The FDA’s decision is based on results from the ODYSSEY OUTCOMES clinical trial that evaluated Praluent in conjunction with maximally tolerated statins in a total of 18,924 subjects that experienced an acute coronary syndrome (ACS) within a year of enrolling in the study.

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ODYSSEY OUTCOMES was designed to track the effect of the combination on CV. The primary endpoint of the trial was time to first heart attack, stroke, death from coronary heart disease (CHD) or unstable angina requiring hospitalisation.

Participants on Praluent were found to experience a 15% decrease in the risk for major CV events, 27% for risk of stroke, 14% for risk of non-fatal heart attack and a 39% decline in the risk of unstable angina requiring hospitalisation.

In addition, patients also had a 15% reduced risk of death from any cause.

Sanofi research and development (R&D) global head John Reed said: “Praluent has already 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.”

In February this year, Regeneron and Sanofi have lowered the list price of Praluent in the US by approximately 60%.