The European Medicines Agency and the European Commission both granted IXIARO its new status. The EC decision ratifies a positive opinion written in December by the European Committee for Human Medical Products. Acceptance by the European Union provides formal marketing approval for all 27 member states, as well as Norway, Liechtenstein and Iceland.
“We are delighted that our JE vaccine has been granted pediatric licensure in Europe, which will now enable travelers of all ages to obtain protection against this disease with a licensed vaccine,” Thomas Lingelbach, Intercell’s CEO, said. “The approval of IXARO for children is based on additional clinical studies that have once more confirmed the favorable safety and immunogenicity profile of the vaccine.”
Intercell submitted an application for pediatric licensure in the second quarter of 2012. Its application was based on data obtained from a Phase III clinical study conducted in the Philippines and favorable interim date from a Phase II trial conducted in the EU, U.S. and Australia. In both studies, the vaccine was shown to be safe and effective in children between the ages of two months and 18 years. Its safety profile compares to other licensed pediatric medicines.