FDA Approves PCSK9 Inhibitor Praluent (Alirocumab) with New Indication Demonstrating 27% Reduction in Stroke Risk

Recently, Regeneron Pharmaceuticals and Sanofi announced that the FDA has approved Praluent (alirocumab), developed through their collaboration, to reduce the risk of heart attack, stroke, and angina requiring hospitalization in patients with cardiovascular disease. Praluent is the first PCSK9 inhibitor demonstrated to meaningfully reduce all-cause mortality.

High levels of low-density lipoprotein cholesterol (LDL-C) in the blood, also known as "bad" cholesterol, can increase the risk of serious cardiovascular events in patients. Adults who have experienced a heart attack or stroke may face up to a one-in-three risk of experiencing another serious cardiovascular event.

Praluent is the first PCSK9 inhibitor approved by the FDA. It works by inhibiting the binding of PCSK9 to LDL receptors, allowing more LDL receptors to return to the surface of liver cells and facilitating the clearance of LDL from the bloodstream. This helps lower LDL levels in the blood. Praluent has been approved in more than 60 countries worldwide. It has received FDA approval for use in combination with diet regulation or other lipid-lowering medications to help patients with hyperlipidemia reduce their LDL-C levels.

This approval is based on the performance of Praluent in the ODYSSEY OUTCOMES trial. In this randomized, double-blind, placebo-controlled, multicenter clinical trial, 18,924 patients who had experienced an acute coronary syndrome (ACS) within the past year received treatment with either Praluent or placebo. These patients were already receiving maximally tolerated statin therapy.

The trial results demonstrated that patients treated with Pauluent had a 15% reduced risk of major adverse cardiovascular events (p=0.0003), a 27% reduced risk of stroke, a 14% reduced risk of non-fatal myocardial infarction, and a 39% reduced risk of unstable angina requiring hospitalization. Meanwhile, the risk of all-cause mortality was reduced by 15% (p=0.026).

“Today’s FDA approval represents a significant advance for adult patients with cardiovascular disease, who are at risk of death or disability due to major cardiovascular events,” said Dr. John Reed, Global Head of Research and Development at Sanofi. “Praluent has already helped many patients lower their LDL-C levels, and this new indication will help reduce the risk of life-threatening major cardiovascular events.”

References:

[1] FDA Approves Praluent? (alirocumab) to Prevent Heart Attack, Stroke and Unstable Angina Requiring Hospitalization. Retrieved April 26, 2019, from https://www.prnewswire.com/news-releases/fda-approves-praluent-alirocumab-to-prevent-heart-attack-stroke-and-unstable-angina-requiring-hospitalization-300839345.html

Source: WuXi AppTec