Late-Onset Pompe Disease Treatment Approved

5/26/2010
The FDA has approved Genzyme Corporation’s Lumizyme (alglucosidase alfa) for patients 8 years of age and older with late (noninfantile)-onset Pompe disease (alpha-glucosidase deficiency) who do not have evidence of cardiac hypertrophy. Genzyme will market 2 approved alglucosidase alfa products and will implement a Risk Evaluation and Mitigation Strategy, the Lumizyme ACE (alglucosidase alfa control and education) Program, to ensure appropriate use for the intended patient populations. All Lumizyme prescribers and health care facilities dispensing and administering Lumizyme are required to be certified and enrolled in the Lumizyme ACE program prior to treating patients. Patients must also be enrolled in the program to receive therapy. Program enrollment will begin immediately to certify prescribers and health care facilities and to help prescribers enroll all patients they intend to treat with Lumizyme.
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