Sanofi and Regeneron Pharmaceuticals wins US FDA's EMDAC recommendation for the approval of investigational therapy Praluent Injection in reducing LDL-C.
M2 PHARMA-June 10, 2015-Sanofi and Regeneron Pharmaceuticals wins US FDA's EMDAC recommendation for the approval of investigational therapy Praluent Injection in reducing LDL-C
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Healthcare company Sanofi (NYSE:SNY) and Regeneron Pharmaceuticals reported on Tuesday the receipt of the US Food and Drug Administration's (FDA) Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) recommendation for the approval of the investigational therapy Praluent (alirocumab) Injection in reducing LDL-C.
The US FDA's EMDAC Committee voted 13 to 3 (with no abstentions) that the companies had sufficiently established 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.
According to the companies, the Committee's recommendation was based on Praluent's benefit-risk profile, following review of efficacy and safety data from more than 5,000 patients across ten pivotal Phase 3 double-blind trials ranging from six months to two years. Clinical data show consistent, positive results in reducing LDL-C.
In addition, the Advisory Committee's recommendation will be considered by the US FDA in its review of the Biologics License Application (BLA) for Praluent. The BLA for Praluent was accepted for priority review by the US FDA, with a target action date of 24 July 2015.
Upon approval by the US FDA, Praluent is expected to be the first fully human monoclonal antibody targeting PCSK9 (proprotein convertase subtilisin/kexin type 9) in the US. The safety and efficacy of Praluent have not been fully evaluated by any regulatory authority, concluded the company.
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|Date:||Jun 10, 2015|
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