Regeneron (REGN) PRALUEN Panel Commentary Could Result in Narrower-Than-Expected Labeling, BMO Capital Says
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FDA Advisory Committee Recommends Approval of Sanofi and Regeneron's Praluent® (alirocumab) Injection for Patients with Hypercholesterolemia
June 9, 2015 6:40 PM EDTPARIS and TARRYTOWN, N.Y., June 9, 2015 /PRNewswire/ -- Sanofi and Regeneron Pharmaceuticals, Inc. today announced that the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) of the U.S. Food and Drug Administration (FDA) recommended the approval of the investigational therapy Praluent® (alirocumab) Injection. The Committee voted 13 to 3 (with no abstentions) that Sanofi and Regeneron had sufficiently established that the low-density lipoprotein cholesterol (LDL-C, or bad cholesterol) lowering benefit of Praluent exceeds its... More
FDA Advisory Committee Recommends Approval of Regeneron and Sanofi's Praluent® (alirocumab) Injection for Patients with Hypercholesterolemia
June 9, 2015 6:30 PM EDTTARRYTOWN, N.Y. and PARIS, June 9, 2015 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) of the U.S. Food and Drug Administration (FDA) recommended the approval of the investigational therapy Praluent® (alirocumab) Injection.
The Committee voted 13 to three (with no abstentions) that Regeneron and Sanofi 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.
"We are pleased with the Committee's recommendation to... More
