Shire has received European Commission marketing authorisation for VPRIV (velaglucerase alfa), a human cell line derived enzyme replacement therapy for the long-term treatment of type 1 Gaucher disease.
VPRIV has received authorisation as an orphan medicine through Europe’s Centralised Procedure, making it available in 30 countries.
The approval was based on successful data from Shire’s velaglucerase alfa clinical development programme, involving more than 100 Gaucher patients at 24 sites in 10 countries, wherein the drug met all primary endpoints.
Professor Tim Cox, founder of the UK’s largest Gaucher clinic, said that Gaucher disease is a rare and often debilitating condition.
“European approval of VPRIV is important in that we now have an alternative, licensed therapeutic enzyme,” Cox said.