Cambridge, Mass.-based Genzyme, a Sanofi company, said the FDA has approved its manufacturing plant in Framingham, Mass., for the production of Fabrazyme (agalsidase beta). This follows the previously announced approval by the EMA last week.
“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 CEO David Meeker.
Approval of the Framingham site allows Genzyme to begin the process of returning patients to full dosing (1mg/kg) levels. Following the EMA approval, Genzyme will begin the process of moving the most severely affected patients in Europe to full doses of Fabrazyme in the first quarter. Beginning in March, all patients in the U.S. currently on therapy will be returned to full dosing. In addition, the company will begin to transition new patients in the U.S. onto Fabrazyme at full dosing levels.
Globally, the complete return to normal supply levels of Fabrazyme will begin in the second quarter and continue throughout the year as planned, as Genzyme works to obtain all global regulatory approvals throughout 2012 and build inventory.