Shire submits regulatory filings for Massachusetts Vpriv plant
Shire has submitted EMA and FDA regulatory filings to add ‘substantial manufacturing capacity’ for Vpriv (velaglucerase alfa).
Regulatory approval of the Lexington, Massachusetts plant will allow Shire to ramp up production of its Gaucher disease treatment Vpriv. Shire expects to receive approval early in 2012.
“Accelerating the completion of our new manufacturing facility in Lexington will enable us to provide substantial additional capacity for Vpriv less than two years after launch”, Bill Ciambrone, senior vice president, technical operations at Shire, said.
Shire’s other product, Replagal (agalsidase alfa), could also benefit from the approval. Currently Shire manufactures both products at its Alewife, Massachusetts plant and moving Vpriv to the new facility will free up capacity for Replagal.
