Sanofi and its Genzyme subsidiary said Tuesday US Regulators have approved its manufacturing plant in Framingham, Mass. or the production of Fabrazyme.
The company received approval from the European Medicines Agency last week.
“We are very pleased with the FDA approval … as we continue our manufacturing recovery and path forward to serve the Fabry patient community,” said Genzyme president and CEO David Meeker.
He said with the approval, the company continues along its 2012 plan “to restore unconstrained supply for all patients globally throughout the year.”
The approval allows Genzyme to begin the process or returning patients to full dosing levels of 1 mg/kg. the most severely affected patients in Europe will resume their full dose by the first quarter of 2012. In March all patients in the U.S. currently on therapy will be returned to full dosing.
The company expects a complete return to normal supply levels of Fabrazyme will begin in the second quarter and continue throughout the year as planned.
The company said it seeking to obtain all global regulatory approvals throughout the year and to build inventory.