The U.S. Food and Drug Administration's (FDA) Endocronilogic and Metabolic Drugs Committee (EMDAC) recently recommended approving the use of Praluent (Alirocumab) to treat high cholesterol.
The medication is being produced by Sanofi and Regeneron Pharmaceuticals, Inc.
"We are pleased with the committee's recommendation to approve Praluent," Dr. Elias Zerhouni, president of Global R&D at Sanofi, said. "Our clinical trial program focused on patients with high unmet need in which Praluent delivered significant reductions in LDL-C on top of statins and other lipid-lowering therapies. Our Phase 3 Praluent development program investigated both a 75 mg and 150 mg dose, providing flexible dosing regimens that can be tailored to individual patient cholesterol level needs."
The EMDAC’s recommendation was based on Praluent’s benefits, which significantly outweighed the risks during trials, including data from more than 5,000 patients in 10 Phase Three trials. The most common adverse reactions were injection site reaction and itching.
The recommendation will be considered by the FDA in its review of the Biologics License Application (BLA) for Praluent. The FDA is not bound by the committee's recommendation, but takes its advice into consideration when reviewing investigational medicines. The BLA for Praluent was accepted for priority review by the FDA with a target action date of July 24.
If approved by the FDA, Praluent is expected to be the first fully human monoclonal antibody targeting PCSK9 (proprotein convertase subtilisin/kexin type 9) in the U.S.
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