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January 22, 2010

Genzyme Waiting For FDA Approval

Genzyme, the Cambridge-based drug company with operations in Framingham and elsewhere in MetroWest, expects a response from the Food and Drug Administration on one of the company's drugs by June.

Lumizyme is a therapy currently in a temporary access phase across the country to treat Pompe disease. Genzyme has been providing therapy for free to 170 patients since 2007 as part of the program. The temporary access will continue until Genzyme receives commercial approval. The company has received a June 17 date for a response to the application.

The drug is already being produced in Belgium and is marketed outside the United States as Myozyme in 40 countries.

The company's development of a treatment for Pompe disease has been fictionalized in the recently released movie "Extraordinary Measures."

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