Jan 21 2010
Genzyme
Corporation (Nasdaq: GENZ) 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.
Source: Genzyme
Corporation