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Genzyme Plant Approved to Begin Manufacture of Drug in Critically Short Supply
Sanofi's subsidiary Genzyme has received FDA's approval for the production of Fabrazyme (agalsidase beta), used in the treatment of Fabry's disease, at its manufacturing facility in Framingham, Massachusetts. Shortages of Fabrazyme have been ongoing for the past two years.
Genzyme, a unit of Sanofi, announced in a press release that FDA had approved its manufacturing facility in Framingham, Massachusetts, for production of Fabrazyme (agalsidase beta). Fabrazyme is used in the treatment of Fabry’s disease, a rare genetic disorder for which it is the only FDA-approved treatment. The company announced EMA approval for the plant on Jan. 18, 2012.
According to the press release, the company expects all patients in the US currently on therapy to be returned to full dosing beginning in March. Globally, the company expects a complete return to normal supply levels of Fabrazyme to begin in the second quarter and continue throughout the year. Genzyme will begin the process of moving the most severely affected patients in Europe to full doses of Fabrazyme in the first quarter of 2012.
Shortages of Fabrazyme have been ongoing for the past two years. Problems began in 2009 with GMP deficiencies found during an inspection of its Allston, Massachusetts, plant that culminated in a consent decree in May of 2010. Since that time, Fabrazyme has been in short supply, leading to rationing of the drug and frustration among patients.
Genzyme’s President and CEO David Meeker said in the release, “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. With this approval, we continue upon our 2012 plan to restore unconstrained supply for all patients globally throughout the course of the year.”