Genzyme received approval from the European Commission for the production of Myozyme (alglucosidase alfa) at the 4000 liter bioreactor scale at its manufacturing facility in Geel, Belgium. The product will be made commercially available immediately. Myozyme is the only approved treatment for Pompe disease, a progressively debilitating and often fatal inherited disorder.

“This approval is important because it ensures that we can supply Myozyme to all patients in Europe who need treatment,” said Genzyme senior vice president Geoff McDonough. “We are grateful to all of the European authorities for their swift action on our application, and to the patients and physicians globally who helped us to conserve product supply over the past two months.”

During January and February, the product was conserved through patient compliance with the request to adjust infusion schedules to preserve product supply for infants and children. With this approval, the availability of product supply will allow adult patients to resume regular infusion schedules, and will allow new patients to initiate therapy.