The FDA has approved alirocumab injection (Praluent, Sanofi/Regeneron) — a proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitor — to lower LDL cholesterol in patients with heterozygous familial hypercholesterolemia (HeFH) or atherosclerotic cardiovascular disease (CVD), according to an agency press release.
Praluent is the first PCSK9 inhibitor to be approved in the U.S. The FDA’s decision comes on the heels of a positive recommendation from the agency’s Endocrinologic and Metabolic Drugs Advisory Committee in June.
The drug’s safety and efficacy were studied in five placebo-controlled trials involving 2,476 participants who took Praluent. All had HeFH or were at high risk for heart attack or stroke and were taking maximally tolerated doses of a statin, with or without other lipid-modifying therapies.
Compared with placebo, the average reduction in LDL cholesterol ranged from 36% to 59% among those taking Praluent vs. placebo.
A trial evaluating the effect of adding Praluent to statins on reducing cardiovascular risk is ongoing, according to the release.
Common side effects of Praluent include itching, swelling, pain or bruising at the injection site, nasopharyngitis and flu. Allergic reactions, such as hypersensitivity vasculitis and hypersensitivity reactions requiring hospitalization, have been reported.
“Praluent provides another treatment option for patients with HeFH or with known cardiovascular disease who have not been able to lower their LDL cholesterol enough on statins,” John Jenkins, MD, director of the Office of New Drugs, Center for Drug Evaluation and Research, said in the release.
“The FDA strongly supports continued work to provide new and innovative options for the treatment and prevention of cardiovascular disease.”