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news.Genzyme, a biotechnology company, has announced that the European Commission has approved the production of Myozyme at the 4,000 liter bioreactor scale at its manufacturing facility in Geel, Belgium.
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The product will be made commercially available immediately, said Genzyme. Myozyme is reported to be the only approved treatment for Pompe disease, a progressively debilitating and often fatal inherited disorder.
During January and February 2009, there was widespread adult patient compliance with the request to adjust infusion schedules to preserve product supply for infants and children, the company said. With this approval, the availability of product supply will now enable adult patients internationally to resume regular infusion schedules, and will allow new patients to initiate therapy, the company added.
Geoff McDonough, senior vice president at Genzyme, said: “This approval is important because it ensures that we can supply Myozyme to all patients in Europe who need treatment. 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.”