Genzyme announced the FDA approval of Lumizyme (alglucosidase alfa), a lysosomal glycogen-specific enzyme, for the treatment of patients ≥8 years of age with late (non-infantile) onset Pompe disease (acid α-glucosidase (GAA) deficiency) who do not have evidence of cardiac hypertrophy. Lumizyme is administered to patients intravenously every two weeks. This approval was based on data from a randomized double-blind, placebo-controlled clinical study in 90 patients (ages 10–70 years) with late-onset Pompe disease.
Lumizyme will be available only through a restricted distribution program called the Lumizyme ACE Program. Only prescribers and healthcare facilities enrolled in the program may prescribe, dispense, or administer Lumizyme.
For more information or to enroll in the Lumizyme ACE Program call (800) 745-4447 or visit www.genzyme.com.