Therapy Areas: Hereditary Disorders
FDA approves production of Fabrazyme at Genzyme's Framingham plant
24 January 2012 - Genzyme Corp, a subsidiary of France's Sanofi SA (EPA:SAN), said on Tuesday that the US Food and Drug Administration (FDA) had given the green light for the launch of production of Fabrazyme (agalsidase beta) at the company's manufacturing plant in Framingham, Massachusetts.

The plant received an approval from the European Medicines Agency (EMA) last week.

The FDA approval for the Framingham site allows Genzyme to begin the process of returning patients to full dosing (1 mg/kg) levels. The EMA approval also allows Genzyme to start the process of moving the most severely affected patients in Europe to full dose of Fabrazyme in the first three months of 2012. All patients in the US will be returned to full dosing starting in March, while the global return to normal supply levels will begin in the second quarter.
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