14th Feb 2014 14:20
SAINT HELIER (Alliance News) - Shire PLC. announced Friday that the US Food & Drug Administration or FDA has approved the production of Vpriv drug substance (velaglucerase alfa for injection) in the company's manufacturing facility at 400 Shire Way, Lexington, Massachusetts, US.
The facility was previously approved by the European Medicines Agency or EMA for production of Vpriv drug substance.
"FDA approval of Shire's manufacturing facility in Lexington provides greater assurance that Gaucher patients will receive consistent and uninterrupted access to enzyme replacement therapy for the treatment of type 1 Gaucher disease," said Rhonda Buyers, CEO and Executive Director, National Gaucher Foundation.
Shire noted that it has invested over USD200 million in manufacturing infrastructure and technology to establish a consistent drug supply chain to patients that use this treatment. The 400 Shire Way facility is the first commercially licensed facility in the world to utilize single-use bioreactor and disposable technology throughout cell culture processing designed to reduce manufacturing risk.
Shire noted that it now has two FDA and EMA approved facilities in which to manufacture Vpriv drug substance - the Alewife and the Lexington facilities, both in Massachusetts, US.
Vpriv is made in a human cell line using Shire's gene activation technology. The enzyme produced has the exact human amino acid sequence as that found in the naturally occurring human enzyme.
Vpriv is used for the long-term treatment of patients with type 1 Gaucher disease.
Vpriv is approved in over 40 countries globally, including the US, the EU member states, and Israel, and is for patients previously treated for type 1 Gaucher disease or those who are treatment-naive.
Copyright RTT News/dpa-AFX
Related Shares:
Shire