"Genzyme, a Sanofi company (EURONEXT: SAN and NYSE: SNY), today announced that the U.S. Food and Drug Administration (FDA) approved a supplement to expand the indication for Lumizyme® (alglucosidase alfa). Lumizyme manufactured at the 4000L scale is now indicated for all Pompe patients of any age or phenotype. The approval of this indication is now consistent with that of the rest of the world, where alglucosidase alfa manufactured at the 4000L is the only scale available. Previously, in the United States, Lumizyme had been approved only for patients with late onset Pompe disease.
W are thankful to the entire Pompe community who has been on this journey to provide a sustainable, long-term option for Pompe patients in the United States, said Genzyme President and CEO, David Meeker, M.D. We are pleased we can now offer alglucosidase alfa produced at the 4000L scale to all patients in the US.
In the United States, alglucosidase alfa is manufactured at two different production scales. Alglucosidase alfa manufactured at the 160L scale (initial pilot scale) has a brand name of Myozyme® (alglucosidase alfa) and alglucosidase alfa manufactured at the 4000L (final manufacturing scale) has a brand name of Lumizyme.
Based on the biochemical and clinical data provided as part of the submission, FDA concluded that alglucosidase alfa manufactured at both scales in the US (i.e., Lumizyme and Myozyme) are comparable. The overall safety profile of alglucosidase alfa remains unchanged. ...
Lumizyme, marketed as Myozyme outside of U.S., is approved in more than 65 countries. For the complete Lumizyme label, visit www.lumizyme.com."
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