FDA Advisory Committee Recommends Approval of Sanofi and...

FDA Advisory Committee Recommends Approval of Sanofi and Regeneron's Praluent Injection for Patients with Hypercholesterolemia Paris and Tarrytown, New York - June 9, 2015 - Sanofi and Regeneron Pharmaceuticals, Inc. today announced that the Endocrinologic and Metabolic Drugs Advisory Committee of the U.S. Food and Drug Administration recommended the approval of the investigational therapy Praluent Injection. The Committee voted 13 to three that Sanofi and Regeneron had sufficiently established that the low-density lipoprotein cholesterol lowering benefit of Praluent exceeds its risks to support approval in one or more patient populations.
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