Ixiaro(R) Receives FDA Approval for the Prevention of Japanese Encephalitis

Th eFDA has approved Ixiaro vaccine for the prevention of Japanese Encephalitis (JE). The vaccine will be marketed in the US as Ixiaro by Novartis Vaccines. JE, a mosquito-borne flaviviral infection, is a devastating disease that results in 10,000-15,000 deaths annually and is a potential threat for travelers to Asia. Ixiaro was developed to provide a well-tolerated, effective and convenient vaccine against JE, suitable for administration to travelers who wish to reduce their risk of acquiring the disease. A vaccine against Japanese Encephalitis has been available for travelers from the US, however its use has been limited by concerns over its safety profile and a recent announcement of discontinued production. Ixiaro has been shown to be as immunogenic as the currently licensed JE vaccine but with a better local tolerability profile and a more convenient dosing schedule. “Asia is now the second most popular travel destination globally, and travel to the region is expected to increase. JE is spread by mosquitoes, which makes it unpredictable. Vaccination is the most effective preventive measure against the disease,” said Dr. Andrin Oswald, CEO of Novartis Vaccines and Diagnostics. Ixiaro was developed by Intercell AG. Novartis and Intercell have a strategic alliance based on a shared vision of science in vaccines R&D. The alliance provides Novartis with the development and commercialization rights to Intercell’s entire non-partnered early state vaccines pipeline. Ixiaro received a positive opinion from the CHMP (European Committee for Human Medicinal Products) of the European Medicines Agency on the Marketing Authorization in December 2008. Further pediatric studies with the vaccine are planned.