FDA approves Lumizyme for infantile Pompe's, says comparable to Myozyme

FDA expanded the label of Lumizyme alglucosidase alfa from the Genzyme Corp. unit of Sanofi (Euronext:SAN; NYSE:SNY) to include treatment of all patients with Pompe's disease. The agency also lifted a REMS that ensured the drug was used only in its previously approved population -- patients ages 8 and up who do not have evidence of cardiac hypertrophy. The product is recombinant human acid alpha glucosidase enzyme ( rhGAA).

Additionally, FDA determined that Lumizyme and Myozyme -- alglucosidase alfa produced from the same cell line as Lumizyme at a different production scale -- are "chemically and biochemically comparable." Lumizyme is produced at Genzyme's 4,000L manufacturing plant, while Myozyme is produced at the 160L scale. The determination comes after the agency's 2008 decision that the larger-scale product would require a separate BLA for approval, citing differences in the carbohydrate structure of the molecules produced in the larger bioreactors (see BioCentury, April 28, 2008). ...