Sanofi and Genzyme receive backing for Fabrazyme production deal

Sanofi and its subsidiary Genzyme have received clearance from European healthcare regulators for a new manufacturing arrangement for the drug Fabrazyme.

The companies have been granted approval by the European Medicines Agency (EMA) to utilise their facility in Framingham, Massachusetts for the production of the agalsidase beta-based therapy for Fabry disease.

Normal supply levels of the drug will not be resumed immediately, as it will still take Sanofi and Genzyme some time to secure all relevant global regulatory approvals, while also factoring in production lead times.

David Meeker, president and chief executive officer of Genzyme, said the resumption of Fabrazyme production is one of the company's highest priorities.

"This approval by the EMA represents an important milestone in our manufacturing recovery and path toward unconstrained supply for all patients," he added.

Earlier this month, Sanofi announced the launch of a new start-up biotechnology company called Warp Drive Bio, in collaboration with Third Rock Ventures and Greylock Partners.