BioMarin (BMRN) Active; Vimizim Docs Posted Ahead of Nov. 19th FDA Panel

BioMarin Pharmaceuticals, Inc. (NASDAQ: BMRN) on watch Friday as the U.S. FDA posted briefing docs for its Vimizim ahead of an Endocrinologic and Metabolic Drugs Advisory Committee meeting on November 19th.

BioMarin previously noted that the FDA granted Vimizim priority review designation and assigned a PDUFA date of February 28, 2014. The company also stated, The European Medicines Agency (EMA) has validated the Vimizim Marketing Authorization Application (MAA) and has granted accelerated review status, which could lead to a (Committee for Medicinal Products for Human Use) CHMP opinion before year end. During the second quarter of 2013, the company also submitted the Marketing Authorisation (MA) in Brazil. Ongoing production of bulk drug substance and drug product will allow for a global launch of Vimizim following approvals in multiple countries. Both the FDA and EMA have conducted or scheduled pre-approval inspections associated with the review of the marketing applications.

The documents (in pdf format) can be accessed here.

Shares of BioMarin are down over 2 percent Friday morning.

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