The European Medicines Agency (EMA) has approved Genzyme’s manufacturing plant in Framingham, Massachusetts, US for the production of Fabrazyme (agalsidase beta).
Fabrazyme (agalsidase beta) is used to treat patients with Fabry disease. Fabrazyme lowers the amount of a substance called globotriaosylceramide (GL-3), which builds up in cells lining the blood vessels of the kidney and certain other cells.
According to Genzyme, the complete return to normal supply levels of Fabrazyme globally will not be immediate due to production lead times and pending regulatory approvals.
Genzyme president and CEO David Meeker said the approval by the EMA represents an important milestone in their manufacturing recovery and path toward unconstrained supply for all patients.
“Providing the Fabry community with consistent access to treatment, increasing our inventory of Fabrazyme and working toward all regulatory approvals of our Framingham plant are our highest priorities,” Meeker added.