Sanofi, French drugmaker that acquired Genzyme Corp. last year, has reported that U.S. drug regulators have approved the new plant allowing Genzyme to work for full supply of one of its products.
Sanofi said in an email based statement on Tuesday that U.S. Food and Drug Administration (FDA) has approved the Framingham, Massachusetts, facility for the production of Fabrazyme (agalsidase beta), a treatment for Fabry disease. European Union regulators approved it on January 18 as announced by the company.
“Genzyme was an important acquisition for Sanofi and today’s announcement shows its recovery is on track,” Eric Le Berrigaud, an analyst at Bryan, Garnier & Co. in Paris, said in a telephone interview today. “Sanofi managed to keep its commitment. It’s important.”
“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’s President and CEO David Meeker. “With this approval, we continue upon our 2012 plan to restore unconstrained supply for all patients globally throughout the course of the year.”
According to the company, this approval of the Framingham site will allow Genzyme to start the process of returning the patients to full dosing levels, i.e. 1 mg/kg, in U.S.
Genzyme / Sanofi