“This approval by the EMA represents an important milestone in our manufacturing recovery and path toward unconstrained supply for all patients,” said Genzyme’s President and CEO David Meeker in a statement release by the company. “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.”
The complete return to normal supply levels of Fabrazyme® globally will not be immediate, as it will take time to obtain all global regulatory approvals throughout the year and due to production lead times, said Genzyme.
Fabrazyme is a man-made form of the naturally-occurring enzyme a-galactosidase A. A deficiency of the enzyme a-galactosidase A is called Fabry disease, a genetic disorder. It reduces deposits of globotriaosylceramide (GL-3) in the kidneys and other certain other cells in the body. Fabrazyme is used in the treatment of Fabry disease.
Genzyme currently holds the exclusive manufacturing license to Fabrazyme, a life-saving drug.
But the company was waiting on approvals to return to full production at the Framingham plant, located on New York Avenue and built in 2009.
Genzyme was sold in April 2011 to Sanofi for $20.1 billion.