FDA extends Myozyme PDUFA date

Genzyme (NASDAQ:GENZ) said FDA extended the PDUFA date for a BLA for Myozyme alglucosidase alfa produced in a 2000-liter bioreactor by three months to Feb. 28 from Nov. 29. The extension follows the company's submission of a risk evaluation and mitigation strategy (REMS). Genzyme said it did not expect the delay to affect its 2009 non-GAAP EPS. In October, FDA's Endocrinologic and Metabolic Drugs Advisory Committee recommended approval of the 2000-liter version of the recombinant human acid alpha-glucosidase enzyme (rhGAA) to treat Pompe's disease. Myozyme produced in a 160-liter bioreactor was approved in 2006 (See BioCentury, Oct. 27, 2008). ...