Sanofi's Genzyme unit announced Tuesday that the FDA approved manufacturing at the company's Framingham, Massachusetts plant for the production of Fabrazyme (agalsidase beta). Genzyme CEO David Meeker noted that "with this approval, we continue upon our 2012 plan to restore unconstrained supply [of Fabrazyme] for all patients globally throughout the course of the year."
Supplies of the Fabry disease treatment were disrupted in 2009 after viral contamination at Genzyme's plant in Allston, Massachusetts. The company said that approval of the Framingham site will allow it "to begin the process of returning patients to full dosing (1 mg/kg) levels" of Fabrazyme. The facility was also recently cleared by the European Medicines Agency.
Genzyme indicated that it "will begin the process of moving the most severely affected patients in Europe to full dose of Fabrazyme" in the first quarter. In the U.S., beginning in March, all patients currently taking the therapy will be returned to full dosing. In addition, the company noted that it will begin to transition new U.S. patients onto Fabrazyme at full dosing levels.
Bryan, Garnier & Co. analyst Eric Le Berrigaud remarked that "Genzyme was an important acquisition for Sanofi and today’s announcement shows its recovery is on track."