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Genzyme Corporation (GENZ) Receives Label Expansion For Lumizyme® (Alglucosidase Alfa) In The United States For The Treatment Of Pompe Disease


8/4/2014 10:50:11 AM

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CAMBRIDGE, Mass.--(BUSINESS WIRE)--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.

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