Genzyme’s Framingham site cleared by FDA
pharmafile | January 24, 2012 | News story | Manufacturing and Production | FDA, Fabrazyme, Fabry, Genzyme
The FDA has cleared Genzyme to begin production of Fabrazyme at its new manufacturing site.
The approval of the new facility in Framingham, Massachusetts means the company will now be able to meet demand for Fabrazyme, its treatment for the rare Fabry disease.
The new plant will boost production volume and allows it to return patients to full dosing levels of Fabrazyme (agalsidase beta) – and potentially see off competition from rival products.
The drug remains in short supply because of quality control issues at the firm’s Allston Landing plant near Boston.
Genzyme was forced to shut down its Allston Landing plant in 2009 after a contamination incident, leading to enforced rationing and dosage restrictions for Fabrazyme, amongst other drugs.
The company said it would begin the process of moving the most severely affected patients in Europe to full dose of Fabrazyme in the coming months, following the EMA approval of the plant last week.
Beginning in March, all patients in the US currently on therapy will be returned to full dosing, and the firm will also seek to put new patients on the drug, again at the full dose.
The return to normal supply levels of the drug will begin in the second quarter and continue throughout the year as planned, Genzyme said.
The firm added that it could now work to obtain all global regulatory approvals throughout the year, in order to make Fabrazyme available in new markets.
Genzyme’s president and chief executive David Meeker, said: “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.”
Genzyme’s gain is bad news for Shire, whose rival Fabry disease drug Replagal (agalsidase alfa) has been benefitting from the shortfall in Fabrazyme supplies.
Shire too has been held back by capacity constraints, however, and it has been racing to bring a facility in Lexington online to boost supplies. In November 2011 it filed for approval of the new facility with the US and EU regulatory authorities.
Ben Adams
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