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news.Genzyme, a Sanofi company, has announced the FDA approval of its manufacturing plant in Framingham, Massachusetts, US, for the production of Fabrazyme (agalsidase beta).
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The FDA approval will allow Genzyme to begin the process of returning patients to full dosing (1mg/kg) levels.
According to the company, all patients in the US currently on therapy will return to full dosing in March, 2012.
The company will also begin to transition new patients in the US onto Fabrazyme, at full dosing levels.
Genzyme will begin the process of moving the most severely affected patients in Europe to full dose of Fabrazyme in the first quarter of 2012.