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FDA Advisory Committee Recommends Approval of Alirocumab (Praluent) for Patients With Hypercholesterolemia

Agency decision scheduled for July

The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) has recommended the approval of the investigational therapy alirocumab (Praluent, Sanofi/Regeneron). The committee voted 13 to 3 that the sponsors had sufficiently established that the low-density lipoprotein cholesterol (LDL-C)-lowering benefit of alirocumab exceeds its risks.

The committee’s recommendation followed a review of efficacy and safety data on alirocumab from more than 5,000 patients enrolled in 10 pivotal, phase III, double-blind trials ranging from 6 months to 24 months in duration. Data from the ODYSSEY clinical development program showed consistent, positive results in reducing LDL-C. Adverse events that were more frequently reported in patients treated with alirocumab than in the control groups included injection-site reactions and pruritus.

The advisory committee’s recommendation will be considered by the FDA in its review of the biologics license application (BLA) for alirocumab. The FDA is not bound by its committees’ recommendations but takes their advice into consideration when reviewing investigational medications. The BLA for alirocumab was accepted for priority review by the FDA, with a target action date of July 24, 2015.

If approved by the FDA, alirocumab is expected to be the first fully human monoclonal antibody targeting proprotein convertase subtilisin/kexin type 9 (PCSK9) in the U.S.

Source: Sanofi; June 9, 2015.

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