Intercell AG has announced that the CHMP of the European Medicines Agency (EMA) has come to a positive opinion on the Marketing Authorization for IXIARO® in children, a vaccine to protect against Japanese Encephalitis (JE).
The final decision (approval) by the European Commission is expected in February or March 2013.
Intercell has submitted applications for the approval of a JE vaccine pediatric label extension to major regulatory agencies in late Q2 2012 based on data from a Phase III clinical study conducted in the Philippines and favorable interim data from a second Phase III trial in EU, US and Australia.
In both studies the JE vaccine showed to be highly immunogenic in children aged 2 months to <18 years with a safety profile comparable to pediatric vaccines licensed for other diseases.
“We are very pleased about the positive CHMP opinion on the pediatric indication for our JE vaccine. This will be the first time European travelers of all ages can be protected against this dreadful disease with a licensed vaccine", states Thomas Lingelbach, Chief Executive Officer of Intercell AG.
Following the approval and launch of Intercell's vaccine against Japanese Encephalitis for adult travelers and military personnel in Europe, the United States, Canada, Hong Kong, Singapore, Israel (IXIARO®) and Australia and New Zealand (JESPECT®), the development of a vaccine to protect children traveling to endemic areas from Japanese Encephalitis has been a major goal of the Company.
The vaccine to prevent Japanese Encephalitis (JE) is Intercell’s first product on the market. This is a next-generation vaccine used to help prevent infection with the JE virus, and has been licensed in more than 30 countries.
The vaccine is a purified, inactivated vaccine and causes the body to produce its own protection (antibodies) against this disease.
Upon approval of the new indication for the pediatric age segment in the EU, the vaccine will offer protection against JE for adults and children aged 2 months and above who travel to, or live in, endemic areas.
In the U.S. the vaccine is currently licensed for those above 17 years of age, and in Canada, Australia and New Zealand it is licensed for persons above 18 years of age.
In the U.S. the pediatric label extension is currently under review by the FDA.
The vaccine is manufactured by Intercell AG’s wholly-owned subsidiary Intercell Biomedical Ltd. at our cGMP facility in Livingston, Scotland.