Return to normal supply will start in the first quarter
The US FDA has approved Genzyme’s manufacturing plant in Framingham, Massachusetts, US for the production of Fabrazyme (agalsidase beta), a treatment for Fabry disease.
This follows the announcement last week that the European Medicines Agency has approved the plant.
The FDA approval allows Genzyme to begin the process of returning patients to full dosing (1mg/kg) levels.
The company says all patients in the US currently on the drug will return to full dosing in March.
The company will also begin to transition new patients in the US onto Fabrazyme at full dosing levels.
Following the EMA approval, Genzyme will begin the process of moving the most severely affected patients in Europe to full dose of Fabrazyme in the first quarter.
Globally, the complete return to normal supply levels of Fabrazyme will begin in the second quarter and continue throughout the year as planned.