Shire seeks US, EU approval of Mass. facility
LEXINGTON, Mass.—Irish drugmaker Shire PLC has filed an application with U.S. and European regulators to produce its Gaucher disease drug at a new manufacturing site in Massachusetts, saying the move will give it flexibility to meet global demand for treatments of rare diseases.
The company hopes to begin manufacturing Vpriv in Lexington after it receives U.S. Food and Drug Administration and the European Medicines Agency approval to use the facility.
That would also enable the company's rare-diseases division expand capacity to manufacture its Fabry disease treatment Replagal.
Fabry disease is a rare inherited disorder caused by the lack of an enzyme needed to break down a certain type of fat.
Vpriv and Replagal are currently manufactured in Alewife.
Shire's rare-diseases division, known as Human Genetic Therapies, is based in Lexington.