Regulatory briefs: Shire's Vpriv cleared in Europe; Menactra for toddlers; Updates for Novartis and Roche

Ireland-based drugmaker Shire (LSE: SHP) says that the European Commission has granted marketing authorization for Vpriv (velaglucerase alfa), 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 medicine through the Centralised Procedure, making it available in 30 countries across Europe.

This approval, which follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) and has already been approved in the USA (The Pharma Letters June 28 and March 1) was based on data from Shire's velaglucerase alfa clinical development program which represents the largest and most comprehensive clinical data
set supporting registration for an ERT for type 1 Gaucher disease. In total, over 100 Gaucher patients at 24 sites in 10 countries around the world participated in the clinical studies, all of which met their primary endpoints

US FDA accepts Sanofi Pasteur's application to expand Menactra indication to infants and toddlers