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FDA Approves Genzyme’s Lumizyme

Genzyme received marketing approval from the FDA for Lumizyme (alglucosidase alfa), produced at the 4000 L bioreactor scale at its manufacturing facility in Geel, Belgium.

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Genzyme received marketing approval from the FDA for Lumizyme (alglucosidase alfa), produced at the 4000 L bioreactor scale at its manufacturing facility in Geel, Belgium. Lumizyme is the first treatment approved in the U.S. to treat patients with late-onset Pompe disease. Lumizyme is a lysosomal glycogen-specific enzyme for patients eight years and older with late (non-infantile) onset Pompe disease who do not have evidence of cardiac hypertrophy. “This is an important day for the Pompe com...

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