Genzyme Corporation announced today that it has received a June 17, 2010 PDUFA date from the FDA for its Biologics License Application for Lumizyme™ (alglucosidase alfa) seeking approval for the therapy produced at the 4000 L scale. The FDA has classified the resubmission as a class 2 complete response, which carries a six-month review timeframe. Genzyme last month reopened enrollment in the Alglucosidase Alfa Temporary Access Program (ATAP), a program which provides access to treatment for severely affected adults with Pompe disease prior to commercial approval of Lumizyme. The company has provided therapy free of charge to approximately 170 patients since 2007, and is working with the 81 active study sites in the U.S. to enroll additional patients into this program. The ATAP program will remain open until commercial approval of Lumizyme. The 4000 L-scale Lumizyme is produced at Genzyme’s manufacturing plant in Geel, Belgium. Lumizyme is marketed outside of the United States as Myozyme® (alglucosidase alfa). Myozyme is commercially approved for the treatment of Pompe disease in approximately 40 countries worldwide.
