FDA panel to discuss two PCSK9 inhibitors

FDA's Endocrinologic and Metabolic Drugs Advisory Committee will convene on consecutive days in June to discuss BLAs for two PCSK9 inhibitors.

The panel will meet June 9 to review a BLA from Sanofi (Euronext:SAN; NYSE:SNY) and Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) for Praluent alirocumab as an adjunct to diet for long-term treatment of adult patients with primary hypercholesterolemia or mixed dyslipidemia. Praluent is under Priority Review with a July 24 PDUFA date (see BioCentury, March 9). ...