Intercell AG announced today that the pediatric indication for IXIARO®, a vaccine to protect against Japanese encephalitis (JE), was approved by the US Food and Drug Administration (FDA).
In Europe, the pediatric label extension was granted in February 2013.
“We are very pleased that the FDA has now approved IXIARO® for use in children from the age of 2 months. For the first time in nearly 2 years, a licensed vaccine will now be available to vaccinate also traveling children and those children of forward deployed military personal in Asia, against JE.
This important step is a key element of the further growth for Intercell’s first commercial product and another milestone in the fight against this potentially deadly disease with a licensed vaccine", says Thomas Lingelbach, Chief Executive Officer of Intercell AG.
Intercell submitted applications for pediatric licensure of the JE vaccine 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 was shown to be highly immunogenic in children/adolescents aged 2 months to less than 18 years with a safety profile comparable to pediatric vaccines licensed for other diseases.
Following the approval and launch of Intercell's vaccine against Japanese Encephalitis for adult civilian travelers and military personnel in Europe, Switzerland, 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.
Intercell’s next-generation vaccine to protect travelers against Japanese encephalitis (JE) is currently licensed in more than 35 countries worldwide, and is the Company’s first product on the market.
Extension of the approved indication to include the pediatric age segment in the US allows IXIARO® to be administered to both adults and children aged 2 months and above who travel to, or live in, JEV endemic areas of Asia.
Intercell and its marketing and distribution partners are committed to introducing a new product presentation for IXIARO®, suitable for administration in all approved age groups, as soon as possible.
Product which is currently available on the market in the US can be used in accordance with the approved dosage and administration in individuals aged 3 years and above.
The vaccine is manufactured by Intercell AG’s wholly-owned subsidiary Intercell Biomedical Ltd. at its cGMP facility in Livingston, Scotland.