Genzyme/BioMarin Aldurazyme
Executive Summary
FDA's Endocrinologic & Metabolic Drugs Advisory Committee will consider Genzyme/BioMarin's Aldurazyme (laronidase) for treatment of mucopolysaccharidosis 1 on Jan. 15. A rolling BLA submission for the enzyme replacement therapy was initiated April 12; FDA has granted Aldurazyme orphan drug designation and fast-track status. The meeting begins at 8 a.m. at the Holiday Inn in Bethesda, Md. [To view a 1webcast/video of this meeting, go to FDAAdvisoryCommittee.com]...