Vimizim elosulfase alfa regulatory update

FDA's Endocrinologic and Metabolic Drugs Advisory Committee will meet on Nov. 19 to discuss a BLA for Vimizim elosulfase alfa from BioMarin to treat mucopolysaccharidosis IVA (MPS-IVA, Morquio's syndrome). Vimizim, a recombinant human N-acetylgalactosamine-6-sulfatase, has a Feb. 28, 2014 PDUFA date. FDA granted Priority Review to the BLA, but the agency subsequently extended the PDUFA date by 3 months after BioMarin provided additional CMC information the agency had requested during the initial review of the BLA. ...