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FDA panel backs BioMarin's Vimizim

November 20, 2013 3:18 AM UTC

FDA's Endocrinologic and Metabolic Drugs Advisory Committee backed approval of Vimizim elosulfase alfa from BioMarin Pharmaceutical Inc. (NASDAQ:BMRN) to treat mucopolysaccharidosis IVA (MPS-IVA, Morquio's syndrome). Specifically, 18 panel members voted for approval for Vimizim for all patients, two panel members voted for approval of Vimizim for a subgroup of Morquio's syndrome patients with worse baseline walking abilities and one panel member voted against approval. One of the members who voted for approval in the subgroup subsequently changed her vote in favor of full approval. The recombinant human N-acetylgalactosamine-6-sulfatase has a Feb. 28 PDUFA date. ...