Genzyme's Lumizyme approved with REMS program

With the FDA approval of Lumizyme this week, Genzyme is marketing two alglucosidase alfa products to treat Pompe disease: The new drug joins Myozyme, which gained market approval in 2006. The FDA has required a Risk Evaluation and Mitigation Strategy, and the big biopharma has responded with the Lumizyme ACE (alglucosidase alfa control and education) Program. Prescribers and dispensers will be required to be certified and enrolled in the program prior to the start of treatment. Prescribers must also ensure that patients enroll in the program. Release

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