EMA approves Genzyme plant for Fabrazyme production


Complete return to normal supply levels will not be immediate

The European Medicines Agency (EMA) has approved Genzyme’s manufacturing plant in Framingham, Massachusetts, US for the production of Fabrazyme (agalsidase beta).

Genzyme, the Cambridge, MA division of French pharmaceutical company Sanofi, said the complete return to normal supply levels of Fabrazyme globally would not be immediate, as it will take time to obtain all global regulatory approvals throughout the year.

The firm’s distribution of Fabrazyme, a treatment for Fabry disease, was affected in 2009 by contamination at the Allston Landing plant. In December 2011, Genzyme indicated that it was ready to resume Fabrazyme deliveries in the second half of 2012.

Genzyme’s president and chief executive, David Meeker, said: ‘This approval by the EMA represents an important milestone in our manufacturing recovery and path toward unconstrained supply for all patients.

‘Providing the Fabry community with consistent access to treatment, increasing our inventory of Fabrazyme and working toward all regulatory approvals of our Framingham plant are our highest priorities, and we remain on track to achieve all of these crucial goals.’