Shire submits regulatory filings for VPRIV production
Expects to increase manufacturing capacity at Lexington, MA
Shire, a global biopharmaceutical firm, 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, MA, US.
Subject to regulatory approval, which is anticipated early next year, Shire expects the new plant to increase manufacturing capacity significantly and allow for increased global supply of VPRIV. These approvals will also make available further capacity for the manufacture of Replagal (agalsidase alfa) at Shire’s Alewife facility, where both VPRIV and Replagal are currently manufactured.
The FDA approved VPRIV in February 2010 as a hydrolytic lysosomal glucocerebroside-specific enzyme indicated for long-term enzyme replacement therapy for adult and paediatric patients with type 1 Gaucher disease. In August the same year, the European Commission granted the drug marketing authorisation for VPRIV for the same indication, making it available in 30 countries across Europe. VPRIV is currently approved in 38 countries worldwide.
Replagal is a form of the human enzyme alfa-galactosidase A (α-Gal A) manufactured in a human cell line by gene activation. It is now approved in 46 countries worldwide, but not currently approved for commercial sale in the US.
Replagal is indicated for the long-term treatment of patients with a confirmed diagnosis of Fabry disease (α-Gal A deficiency).
Bill Ciambrone, senior vice president, Technical Operations at Shire HGT, said: ‘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. 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.’
