FDA committee recommends approval of Praluent® Injection to treat hypercholesterolemia

June 11, 2015 - PRLog -- In a 13 to 3 vote, the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) of the U.S. Food and Drug Administration (FDA) recommended the approval of Praluent® (alirocumab) Injection, an investigational therapy developed by Sanofi and Regeneron Pharmaceuticals, Inc to lower high levels of cholesterol in the blood.

"We are pleased with the Committee's recommendation to approve Praluent. 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," said Elias Zerhouni, M.D., President, Global R&D, Sanofi. "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."

Praluent’s benefit –risk profile led to the committee’s recommendation following the review of the safety and efficacy data from 10 pivotal Phase 3 double-blind trials ranging from six months to two years involving 5,000 patients. The Biologic License Application (BLA) for Praluent has been accepted for priority review by the FDA and the target action date is set for July 24, 2015. If approved, Praluent will be the first fully human monoclonal antibody targeting PCSK9 (proprotein convertase subtilisin/kexin type 9) in the U.S.

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