Results Wire: US FDA Advisory Committee Supports Regeneron Pharmaceuticals’ and Sanofi Aventis’ PCSK9 Inhibitor, PRALUENT (Alirocumab), for High Cholesterol, But In Narrower Population Than Proposed – JUN 9, 2015 (EMDAC)
On Tuesday, June 9, 2015. the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) supported, by a vote of 13-Yes to 3-No, with no abstentions, the safety and efficacy of PRALUENT (Alirocumab) for injection, submitted by Sanofi Aventis, U.S. (Sanofi) and Regeneron Pharmaceuticals, Inc. (Regeneron) for the treatment of high cholesterol (BLA Number 125559).