Just over a month after getting the green light from US regulators to produce Fabrazyme from its Framingham, Massachusetts site, Sanofi's Genzyme Corp has begun shipping the Fabry disease drug from the plant.
Genzyme has been plagued by manufacturing problems with Fabrazyme (agalsidase beta) since the temporary closure of its Allston Landing, Boston facility in June 2009. Now it says that patients in the USA are able to receive treatment at full dosing levels.
Genzyme’s chief executive David Meeker said that "the ability to meet the needs of patients in the USA is an important first step in restoring unconstrained supply for all patients globally throughout the course of 2012". In Europe the process of moving the most severely affected patients to full dose of Fabrazyme will begin this month and elsewhere in the second quarter.
The US Food and Drug Administration and the European Medicines Agency approved the Framingham plant for the production of Fabrazyme in January.
Just over a week ago, rival Shire got the green light from the EMA to one of the firm's US manufacturing facilities to produce the Gaucher disease drug Vpriv (velaglucerase alfa) a move which will release further capacity for the manufacturing of Replagal (agalsidase alfa) for Fabry disease at another facility in Massachusetts.
Both Vpriv and Replagal have benefited sales-wise from Genzyme's manufacturing problems with Fabrazyme and Cerezyme (imiglucerase) for Gaucher disease.