PARIS (Reuters) - Sanofi’s unit Genzyme said on Tuesday it had won U.S. regulatory approval for its Framingham, U.S.-based plant that will produce Fabrazyme, aiming to get patients back on their required dosages of the rare disease drug worldwide this year.
The opening of the plant, which won clearance from the European regulator last week, is a critical step in resolving manufacturing woes that have bedeviled Genzyme since before Sanofi acquired the U.S. rare disease specialist last year.
“With this approval, we continue upon our 2012 plan to restore unconstrained supply for all patients globally throughout the course of the year,” Genzyme Chief Executive David Meeker said in a statement.
A viral contamination at one of Genzyme’s plants in 2009 has resulted in shortages of both Fabrazyme, its drug for Fabry disease, and Cerezyme for Gaucher’s disease.
The new biologics production plant, based in the state of Massachusetts, should help remove capacity constraints and enable Genzyme to win back market share it lost to Shire’s Replagal.
Genzyme said it would begin to move the most severely affected patients in Europe to full dose of Fabrazyme in the first quarter of this year. Patients in the U.S. who are already using the drug, will be returned to full dosing in March.
Worldwide, the complete return to normal supply levels of Fabrazyme will begin in the second quarter and continue throughout the year, it said.
Sanofi shares closed at 55.44 euros on Monday.
Reporting by Caroline Jacobs