Genzyme Corporation
Genzyme Receives Complete Response Letter on Lumizyme Application
Published in Law and Health Weekly, December 5th, 2009
Genzyme Corporation (Nasdaq: GENZ) announced 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 stated that satisfactory resolution of deficiencies related to the Allston Landing manufacturing plant are required before the Lumizyme application can be approved. Genzyme believes the other elements of the Lumizyme review, such as the Risk Evaluation and Mitigation Strategy (REMS), the product label, and post-marketing requirements, have been satisfactorily addressed.
The FDA completed its five-week inspection of the Allston plant...
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