Regeneron Pharmaceuticals Inc (REGN) and Sanofi (SNY) on Tuesday said a panel of the U.S. Food and Drug Administration recommended the approval of the investigational therapy Praluent (alirocumab) Injection.
The FDA's Endocrinologic and Metabolic Drugs Advisory Committee voted 13 to three that the low-density lipoprotein cholesterol (LDL-C, or bad cholesterol) lowering benefit of Praluent exceeds its risks to support approval in one or more patient populations.
The Committee's recommendation will be considered by the FDA in its review of the Biologics License Application for Praluent. 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.
The Marketing Authorization Application for Praluent in the European Union is currently under review by the European Medicines Agency (EMA). The safety and efficacy of Praluent have not been fully evaluated by any regulatory authority.
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