Genzyme Gains EMA Approval for Framingham Plant

Genzyme, a Sanofi company, received approval from the EMA for its manufacturing plant in Framingham, MA, for the production of Fabrazyme (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 chief executive officer, David Meeker. “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, and we remain on track to achieve all of these crucial goals.”

Additional global regulatory approvals, anticipated throughout the year, are needed to help return to normal supply levels of Fabrazyme globally.