Shire plc, an Irish drug company with about 1,400 employees at its Lexington research campus, said Friday that it has gotten US regulatory approval to make the Gaucher disease drug Vpriv at its Lexington manufacturing facility.
The facility was previously approved by European regulators for the production of Vpriv. Gaucher disease is a rare genetic disorder.
Shire said it has invested more than $200 million in manufacturing infrastructure and technology to establish a consistent drug supply chain to patients that use this treatment.
Shire said it now has two facilities that have been approved by FDA and European regulators for the production of Vpriv. Besides Lexington, the company also has a facility in the Alewife neighborhood of Cambridge.
Vpriv has been approved in more than 4o countries, including the US, the European Union member states, and Israel.