FDA panel backs Praluent in restricted populations

FDA's Endocrinologic and Metabolic Drugs Advisory Committee voted 13-3 to support approval of Praluent alirocumab from Sanofi (Euronext:SAN; NYSE:SNY) and Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) to treat hyperlipidemia.

Six panel members who supported approval felt that approval of the mAb against PCSK9 should be restricted to patients with heterozygous familial hypercholesterolemia (HeFH), while the other seven thought approval should be extended to high-risk cardiovascular patients whose LDL is not well controlled by maximally tolerated statins. ...