Background
In February 2009, Genzyme received a Complete Response letter from the FDA in regards to the Biologics License Application (BLA) for alglucosidase alfa produced at the 2000L scale which will be called Lumizyme™ in the US. In the letter, the FDA outlined the items that needed to be addressed before approval can be granted.
Update
Genzyme has submitted the final documentation to address all items in the FDA’s complete response letter for the company’s application for Lumizyme.
Included in the submission are clinical data from Genzyme’s Pompe Registry, the Risk Evaluation and Mitigation Strategy (REMS) details and the final labeling. The FDA has agreed that a verification study is no longer necessary. Additionally, Genzyme has completed all measures required to respond to the FDA warning letter regarding the company’s Allston manufacturing facility. The FDA previously informed Genzyme that it would accept the complete response submission and initiate the review without requiring an inspection to occur first. Genzyme anticipates that its filing will be designated as a class 2 resubmission with a six month review period.
Please click here to read full Pompe Program Update (PDF, 11 kB).