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Repatha panelists to discuss LDL surrogate, dose strength

June 9, 2015 2:09 AM UTC

FDA's Endocrinologic and Metabolic Drugs Advisory Committee will discuss LDL-C lowering as a surrogate for cardiovascular benefit as it evaluates a BLA for PCSK9 inhibitor Repatha evolocumab from Amgen Inc. (NASDAQ:AMGN) at a meeting on Wednesday. The discussion on surrogates is expected to echo the same committee's Tuesday evaluation of another registration-stage mAb against PCSK9, Praluent alirocumab from Sanofi (Euronext:SAN; NYSE:SNY) and Regeneron Pharmaceuticals Inc.(NASDAQ:REGN). Both compounds are under review to treat high cholesterol indications.

In a memo accompanying briefing documents for Wednesday's Repatha meeting, James Smith, deputy director of the division of metabolism and endocrinology products at the Center for Drug Evaluation and Research, wrote that the "central issue" for the Repatha BLA is "for what population(s), if any does the LDL-C lowering benefit of evolocumab exceed its risks to support approval?" ...