Genzyme Corporation (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 enrolment in the Alglucosidase Alfa Temporary Access Program (ATAP), a programme 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 US to enrol 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.
One of the world's leading biotechnology companies, Genzyme is dedicated to making a major positive impact on the lives of people with serious diseases. Since 1981, the company has grown from a small start-up to a diversified enterprise with more than 12,000 employees in locations spanning the globe and 2009 revenues of approximately $4.5 billion.