Genzyme Corporation said Tuesday that the FDA has approved its new manufacturing plant in Framingham, Massachusetts, enabling the company to expand its production of Fabrazyme (agalsidase beta) for patients with Fabry disease. Last week, the European Medicines Agency approved the facility.
The back-to-back regulatory actions are good news for patients throughout the world with the rare lysosomal storage disorder who have faced significant restrictions in drug supplies as a result of manufacturing issues.
The approvals mean Genzyme can begin returning patients to full dosing (1 mg/kg) in the next several months and move forward with a yearlong plan to fully rebuild supplies.
“Product from Framingham can now support the return of US patients to full doses as planned. Globally, the complete return to normal supply levels of Fabrazyme will begin in the second quarter and continue throughout the year,” the company said in an update posted on an FDA Website. (http://supplyupdate.genzyme.com/weblog/fabrazyme/)
Additionally, the company said it would start to transition new patients in the United States onto Fabrazyme at full dosing levels.
Genzyme, a Sanofi company, is a biotechnology company headquartered in Cambridge, Massachusetts.