Replagal and Fabrazyme reviews
Executive Summary
Genzyme's Fabrazyme (agalsidase beta) and TKT's Replagal (agalsidase alfa) will be reviewed by FDA's Endocrinologic & Metabolic Drugs Advisory Committee Jan. 13 and 14. The committee was originally slated to review the BLAs on Sept. 26-27. The delay apparently resulted from concerns raised by TKT about potential conflicts of interest among certain committee-invited guests (1"The Pink Sheet" Oct. 7, p. 23). The meeting will begin at 8 a.m. both days at the Holiday Inn in Bethesda, Md. [To view a 2webcast/video of each of these meetings, go to FDAAdvisoryCommittee.com]....
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