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 Lumizyme™ (alglucosidase alfa), 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 Lumizyme. Also included in the submission were the Risk Evaluation and Mitigation Strategy (REMS) and the final label for the product.
Because the submission will include clinical data, Genzyme anticipates that its filing will be designated as a class 2 resubmission with a six-month PDUFA goal. However, given the ongoing dialogue between Genzyme and the FDA, the company expects that the agency will expedite the review process.
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