BioMarin's Vimizim under review in U.S., EU

BioMarin Pharmaceutical Inc. (NASDAQ:BMRN) said FDA and EMA accepted for review regulatory applications for Vimizim elosulfase alfa to treat mucopolysaccharidosis IVA (MPS-IVA, Morquio's syndrome). FDA granted Priority Review to the BLA, but the agency subsequently extended the PDUFA date by three months after BioMarin provided additional CMC information the agency had requested during the initial review of the BLA. The PDUFA date is Feb. 28, 2014. BioMarin said FDA plans to hold an advisory committee meeting to discuss Vimizim, but the meeting hasn't been scheduled.

BioMarin said EMA also granted accelerated assessment to the MAA. The company expects a recommendation from EMA's CHMP in December, with a decision from the European Commission expected in 1Q14. An accelerated assessment shortens the review period to 150 days from 210. ...