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Praluent panelists to consider LDL as surrogate for CV benefit

June 6, 2015 12:57 AM UTC

FDA will ask its Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) to discuss whether LDL-C lowering is a surrogate for cardiovascular benefit of first-in-class PCSK9 inhibitor Praluent alirocumab from Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) and Sanofi (Euronext:SAN; NYSE:SNY).

The request came in briefing documents ahead of EMDAC's Tuesday meeting to review the BLA for Praluent to treat hypercholesterolemia. ...