Genzyme Gains FDA Approval For Framingham Plant

Genzyme, a Sanofi company, received approval from the FDA for its manufacturing plant in Framingham, MA, for the production of Fabrazyme (agalsidase beta). This follows the recent approval by the European Medicines Agency (EMA) last week, and allows Genzyme to begin the process of returning patients to full dosing (1 mg/kg) levels.

“We are very pleased with the FDA approval of our Framingham plant as we continue our manufacturing recovery and path forward to serve the Fabry patient community,” said Genzyme’s president and chief executive officer, David Meeker. “With this approval, we continue upon our 2012 plan to restore unconstrained supply for all patients globally throughout the course of the year.”

Following the EMA approval, Genzyme will begin the process of moving the most severely affected patients in Europe to full dose of Fabrazyme in 1Q12. Beginning in March, all patients in the U.S. currently on therapy will be returned to full dosing. The company will also begin to transition new patients in the U.S. onto Fabrazyme, at full dosing levels. The complete return to normal supply levels of Fabrazyme globally will begin in 2Q12 and continue throughout the year, as Genzyme obtains all the necessary regulatory approvals.