Date: 2012-06-26
Type of information: Granting of a patent
Product name: Vpriv®
Compound: velaglucerase alfa
Therapeutic area: Rare diseases - Genetic diseases
Action mechanism: This hydrolytic lysosomal glucocerebroside-specific enzyme is an enzyme replacement therapy.
Company: Shire (UK - USA)
Disease: Gaucher disease
Latest news: * On February 22, 2012, Shire announced that the EMA Committee for Medicinal Products for Human Use has approved the production of VPRIV® (velaglucerase alfa) in its new state-of-the-art manufacturing facility at 400 Shire Way in Lexington, MA. The European Commission’s decision is expected imminently. Shire now has two EMA approved facilities – Alewife, in Cambridge, MA, as well as the new Lexington facility – in which to manufacture VPRIV® drug substance. This additional capacity will allow Shire to significantly increase global supply of VPRIV® and provides additional manufacturing flexibility. The EMA approval is also a critical first step in releasing further capacity for the manufacturing of REPLAGAL® (agalsidase alfa) at Shire’s Alewife facility. The new facility increases bioreactor capacity from 1000 to 8000L, and is the first commercially licensed facility in the world to utilize single-use bioreactor and disposable technology throughout cell culture processing to reduce manufacturing risk. * On November 22, 2011, Shire has announced that it has submitted regulatory filings with both the EMA and the FDA for the production of VPRIV® (velaglucerase alfa) in its state-of-the-art manufacturing facility at 400 Shire Way in Lexington, Massachusetts. Subject to regulatory approval, which is anticipated in early 2012, Shire expects the new plant to significantly increase manufacturing capacity 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.
Patents:
Submission of marketing authorization application USA :
Submission of marketing authorization application UE:
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
US authorization:
UE authorization: 2010-08-26
Favourable opinion UE:
Favourable opinion USA:
Orphan status USA:
Orphan status UE:
Pediatric exclusivit _USA:
Pediatric exclusivity UE: OTC status: Other news:
