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news.Shire, a global biopharmaceutical, has submitted regulatory filings with the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) for the production of VPRIV (velaglucerase alfa) in its manufacturing facility at Lexington, Massachusetts.
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VPRIV is a hydrolytic lysosomal glucocerebroside-specific enzyme indicated for long-term enzyme replacement therapy in patients with type 1 Gaucher disease.
The company hopes to increase the production capacity and the global supply of VPRIV.
Shire Technical Operations senior vice president Bill Ciambrone said the completion of the facility would provide them additional capacity for VPRIV.
"Once approved, this new facility will give us greater flexibility to meet the global demand for VPRIV as well as some of our other products for rare diseases," Ciambrone added.