Genzyme Receives Complete Response Letter from FDA on Lumizyme Application
Posted on: March 02, 2009 - Filed under
CAMBRIDGE, Mass. – Genzyme Corporation (Nasdaq: GENZ) announced today that it has received a complete response letter from the FDA regarding its application to market Lumizyme™ (alglucosidase alfa) for the treatment of Pompe disease. In its letter, the agency outlines the remaining items that need to be addressed before the application can be approved. Lumizyme is produced at the 2000 liter (L) bioreactor scale at Genzyme’s Allston Landing facility.