GENZ - some good news FDA

Genzyme announced that it has received a complete response letter from the FDA regarding its application to market Lumizyme 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, the product label, and post-marketing requirements, have been satisfactorily addressed.