CAMBRIDGE, Mass. – Genzyme Corporation (Nasdaq: GENZ) announced today that it has submitted the final documentation to address all items in the FDA’s complete response letter for LumizymeTM (alglucosidase alfaA form of enzyme replacement therapy used to treat Pompe disease by providing a lab-made version of ... More), produced at the 2,000 L bioreactor scale.
The submission included clinical data requested by the FDA from Genzyme’s Pompe Registry. The FDA has agreed that these data can fulfill the requirements for a verification study to demonstrate the clinical benefit of LumizymeA form of enzyme replacement therapy used to treat Pompe disease by providing a lab-made version of ... More. Also included in the submission were the Risk Evaluation and Mitigation Strategy (REMS) and the final label for the product.