The FDA has approved Ixiaro (purified, inactivated Japanese Encephalitis virus vaccine, from Intercell) for active immunization against the Japanese Encephalitis virus in adult travelers and military personnel who visit or are deployed to affected countries (eg, India, China, and other parts of Asia). This approval was based on results from Phase III trials that found that Ixiaro demonstrated immunogenicity comparable to JE-Vax (Japanese encephalitis virus vaccine inactivated, from Sanofi Pasteur) with a more favorable local tolerability profile. The overall clinical safety profile for Ixiaro was similar to placebo.
Ixiaro is expected to be made available by Novartis in the second quarter of 2009.
For more information call (301) 556-4500 or visit www.intercell.com.