Shire Gaucher Drug Gains EU Approval

Shire has been granted marketing authorization by the European Commission for VPRIV, a human cell line-derived enzyme replacement therapy (ERT) for the long-term treatment of type 1 Gaucher disease. VPRIV has been authorized as an orphan drug through the Centralized Procedure, making it available in 30 countries in Europe.

This approval was based on data from Shire’s velaglucerase alfa clinical development program in more than 100 Gaucher patients at 24 sites in 10 countries around the world, all of which met their primary endpoints.

“The Marketing Authorization for VPRIV in the EU is an important milestone for Shire,” said Sylvie Gregoire, president, Shire Human Genetic Therapies. “Our efforts to accelerate our manufacturing, clinical and regulatory timelines have resulted in VPRIV’s approval in Europe and the U.S. months ahead of schedule.”