Genzyme said Tuesday it secured U.S. regulatory approval of its Framingham, Mass. biotech factory, a key step in resuming production of its Fabrazyme drug and increasing patient treatments.
The nod from the Food and Drug Administration follows European approval of the factory last week for Genzyme, a unit of drug giant Sanofi that's been struggling with manufacturing problems for several years.
The Cambridge-based company said U.S. patients with the rare Fabry disease "will be returned to full dosing" of Fabrazyme by March.
"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," said Genzyme president David Meeker said in a statement. "With this approval, we continue upon our 2012 plan to restore unconstrained supply for all patients globally throughout the course of the year."
Analysts believe the FDA approval of the Framingham plant will boost Sanofi's stock price. The Paris-based Sanofi acquired Genzyme last year for $20.1 billion.
Genzyme's production woes started in 2009 with a virus contamination in its Allston manufacturing facility, leading to a shortage of top-selling drugs Fabrazyme and Cerezyme, which treats Gaucher's disease.
