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FDA nods to expanded indication of Intercell's Japanese Encephalitis vaccine
21 May 2013 - 21 May 2013 - Austrian vaccine maker Intercell AG (VIE:ICLL) said today the US drug regulator FDA had approved an additional indication of its Ixiaro vaccine against Japanese Encephalitis, to be used in children aged two months and older.

Until now, the product has been authorised in the USA as a therapy for adults only. In Europe, the vaccine was cleared for use in children in February.

The approval was based on results from two Phase III trials, which showed the vaccine has favourable safety and immunogenicity profile in children and adolescents aged between two months and 18 years.

Currently, Ixiaro is licensed in over 35 countries across the globe and is Intercell's first product on the market.
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