FDA Expands Indication for PCSK9 Alirocumab (Praluent)

Patrice Wendling

April 30, 2019

The US Food and Drug Administration has expanded the indication for alirocumab (Praluent, Sanofi/Regeneron) to reduce the risk for myocardial infarction, stroke, and unstable angina requiring hospitalization in adults with established cardiovascular disease (CVD).

The proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor gained initial approval in the United States in 2015 as an adjunct to diet, alone or in combination with statins, to reduce low-density-lipoprotein cholesterol (LDL-C) in adults with heterozygous familial hypercholesterolemia.

The new approval is based on data from the ODYSSEY OUTCOMES trial in 18,924 patients with elevated LDL-C despite maximally tolerated statins who experienced an acute CV event within a year of enrollment.

As previously reported, the trial showed that adding biweekly injections of alirocumab 75 mg or 150 mg every other week reduced the risk for major CV events by 15% and all-cause death by 15% at a median follow-up of 2.8 years compared with placebo.

Adverse events that occurred in 5% or more of patients receiving alirocumab vs placebo included noncardiac chest pain (7.0% vs 6.8%), nasopharyngitis (6.0% vs 5.6%), and myalgia (5.6% vs 5.3%).

"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," Regeneron President and Chief Scientific Officer George D. Yancopoulos, MD, PhD, said in an April 26 news release.

In February, the drug makers cut the list price of the cholesterol-lowering drug by 60%, from more than $14,000 to $5850, after a similar price cut for Amgen's evolocumab (Repatha) and sluggish sales for both PCSK9 inhibitors.

Last month, European Union officials also expanded the label for alirocumab to include CV risk reduction in adults with established atherosclerotic CVD.

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