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 alfaA form of enzyme replacement therapy used to treat Pompe disease by providing a lab-made version of ... More) manufactured at the 4000L scale and its impact on Myozyme® (alglucosidase alfaA form of enzyme replacement therapy used to treat Pompe disease by providing a lab-made version of ... More) 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 LumizymeA form of enzyme replacement therapy used to treat Pompe disease by providing a lab-made version of ... More. LumizymeA form of enzyme replacement therapy used to treat Pompe disease by providing a lab-made version of ... More 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 MyozymeA form of enzyme replacement therapy used to treat Pompe disease by providing a lab-made version of ... More and switched to LumizymeA form of enzyme replacement therapy used to treat Pompe disease by providing a lab-made version of ... More was included. This biochemical data demonstrated that alglucosidase alfaA form of enzyme replacement therapy used to treat Pompe disease by providing a lab-made version of ... More 4000L (LumizymeA form of enzyme replacement therapy used to treat Pompe disease by providing a lab-made version of ... More) is comparable to alglucosidase alfaA form of enzyme replacement therapy used to treat Pompe disease by providing a lab-made version of ... More 160L (MyozymeA form of enzyme replacement therapy used to treat Pompe disease by providing a lab-made version of ... More).
For several years there have been two Genzyme products in the U.S. for the treatment of Pompe Disease – MyozymeA form of enzyme replacement therapy used to treat Pompe disease by providing a lab-made version of ... More (alglucosidase alfaA form of enzyme replacement therapy used to treat Pompe disease by providing a lab-made version of ... More, produced in 160L bioreactors) and LumizymeA form of enzyme replacement therapy used to treat Pompe disease by providing a lab-made version of ... More (alglucosidase alfaA form of enzyme replacement therapy used to treat Pompe disease by providing a lab-made version of ... More, produced in 4000L bioreactors). The expanded LumizymeA form of enzyme replacement therapy used to treat Pompe disease by providing a lab-made version of ... More indication has allowed Genzyme to review the current manufacturing processes for both products. Based on the expanded LumizymeA form of enzyme replacement therapy used to treat Pompe disease by providing a lab-made version of ... More label, the sustainable production capabilities for LumizymeA form of enzyme replacement therapy used to treat Pompe disease by providing a lab-made version of ... More, and the goal to align with current treatment practices worldwide, Genzyme will discontinue production of the MyozymeA form of enzyme replacement therapy used to treat Pompe disease by providing a lab-made version of ... More formulation and shift all production resources to LumizymeA form of enzyme replacement therapy used to treat Pompe disease by providing a lab-made version of ... More.
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