United States Pompe Community Update from Genzyme
Posted on: October 17, 2014 - Filed under
Genzyme would like to share with you an important update regarding the recent United States (U.S.) Food and Drug Administration’s (FDA) approval of an expanded label for Lumizyme® (alglucosidase alfa) manufactured at the 4000L scale and its impact on Myozyme® (alglucosidase alfa) manufactured at the 160L scale.
In our previous communication dated August 1, 2014, we informed you that the U.S. Food and Drug Administration (FDA) approved the supplement to expand the indication for Lumizyme. Lumizyme is now indicated for patients with Pompe Disease with no limitation as to age or phenotype. This approval was based on data that included biochemical analysis as well as clinical data from an investigator sponsored trial in Taiwan in infantile-onset patients. In addition, supportive data from the ADVANCE trial consisting of patients 12 months and older previously treated with Myozyme and switched to Lumizyme was included. This biochemical data demonstrated that alglucosidase alfa 4000L (Lumizyme) is comparable to alglucosidase alfa 160L (Myozyme).
For several years there have been two Genzyme products in the U.S. for the treatment of Pompe Disease - Myozyme (alglucosidase alfa, produced in 160L bioreactors) and Lumizyme (alglucosidase alfa, produced in 4000L bioreactors). The expanded Lumizyme indication has allowed Genzyme to review the current manufacturing processes for both products. Based on the expanded Lumizyme label, the sustainable production capabilities for Lumizyme, and the goal to align with current treatment practices worldwide, Genzyme will discontinue production of the Myozyme formulation and shift all production resources to Lumizyme.
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