Adcom briefing docs portend uphill battle for metreleptin
By Marie Powers
Monday, December 9, 2013
The tone of the briefing document posted by the FDA for Wednesday’s Endocrinologic and Metabolic Drugs Advisory Committee meeting suggested sponsor Amylin Pharmaceutics LLC, a wholly owned subsidiary of Bristol-Myers Squibb Co., may have a skeptical panel on its hands reviewing the biologics license application for metreleptin (recombinant methionyl human leptin) in metabolic disorders associated with lipodystrophy.
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