Genzyme Corp. (GENZ) announced 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 or ATAP, a program which provides access to treatment for severely affected adults with Pompe disease prior to commercial approval of Lumizyme.
Lumizyme is marketed outside of the United States as Myozyme (alglucosidase alfa). Myozyme is commercially approved for the treatment of Pompe disease in about 40 countries worldwide.
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