The European Commission has granted marketing authorization to Ixiaro vaccine for the prevention of Japanese Encephalitis (JE). JE, a mosquito-borne flaviviral infection, results in 10,000-15,000 deaths annually and is a potentially life-threatening disease for travellers to Asia.
Ixiaro was developed to provide a well-tolerated, effective and convenient vaccine against JE, suitable for administration to travellers who wish to reduce their risk of acquiring the disease. Until now there has not been a licensed Japanese Encephalitis vaccine in Europe. JE is highly prevalent in Asia. It has occurred from the islands of the Western Pacific in the east to Pakistan in the west, and from far Eastern Russia and Korea in the north to Northern Australia in the south.
"Asia is a very popular travel destination for Europeans. Since JE is spread by mosquitoes, the threat to travellers is unpredictable," said Dr Andrin Oswald, CEO of Novartis Vaccines and Diagnostics. "Vaccination is the most effective preventive measure against the disease and Ixiaro will address an unmet medical need for travellers from Europe to Asia."
Ixiaro was developed by Intercell AG. Novartis and Intercell have a strategic alliance that provides Novartis with the commercialization rights to Ixiaro. On December 18, 2008, the Committee for Medicinal Products for Human Use (CHMP) recommended to grant marketing authorization to Ixiaro. The European Commission has granted marketing authorization for the 27 countries of the European Union, as well as Norway and Iceland. Ixiaro vaccine also has received marketing authorization in Australia and received FDA approval in the United States on March 30, 2009. Further paediatric studies with the vaccine are planned.
Ixiaro is indicated for active immunization against JE virus for persons 18 years of age and older. Ixiaro is a purified inactivated state-of-the-art JE vaccine that uses cell culture technology.