Shire’s Lexington facility gets an OK for Gaucher disease drug
Irish drug maker Shire plc announced today that European regulators have approved the production of the company’s treatment for Gaucher disease at Shire’s manufacturing facility in Lexington.
In a press release, Shire said it now has two facilities in Massachusetts --- the other is in Cambridge --- that have the approval of European regulators to make Vpriv, the company’s drug for Gaucher disease, a genetic disorder that causes waste to accumulate in the body.
Vpriv is a rival drug to Cerezyme, which is made by Genzyme Corp., now a unit of the French drug maker Sanofi SA. A production setback at Genzyme’s Boston plant several years ago caused a disruption in the supply of Cerezyme. Patients in the United States are back to their regular doses, a Genzyme spokeswoman said. Patients elsewhere in the world should see the end of rationing during the course of this year.
Shire said that the Lexington facility will increase its manufacturing capacity of Vpriv by eight-fold.
Shire has submitted an application to the US Food and Drug Administration that seeks FDA approval for the Lexington facility to make Vpriv for patients in the United States.
Chris Reidy can be reached at reidy@globe.com.
