Genzyme, a Sanofi company, announced today that the European Medicines Agency (EMA) has approved its manufacturing plant in Framingham, Mass., for the production of Fabrazyme(R) (agalsidase beta).
"This approval by the EMA represents an important milestone in our manufacturing recovery and path toward unconstrained supply for all patients," said Genzyme's President and CEO David Meeker. "Providing the Fabry community with consistent access to treatment, increasing our inventory of Fabrazyme(R) and working toward all regulatory approvals of our Framingham plant are our highest priorities, and we remain on track to achieve all of these crucial goals."
The complete return to normal supply levels of Fabrazyme(R) globally will not be immediate, as it will take time to obtain all global regulatory approvals throughout the year and due to production lead times.