Ixiaro® Vaccine Receives Marketing Authorization In Europe To Prevent Japanese Encephalitis
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[1],[2] and is a potentially life-threatening disease 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. 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 travelers 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 travelers 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 pediatric studies with the vaccine are planned.
Ixiaro Pivotal Study Details
A total of 5,102 subjects have participated in eight Ixiaro clinical trials. A randomized, multicenter, observer-blinded Phase III study was conducted to evaluate the immunogenicity of two doses of Ixiaro compared to three doses of the currently licensed vaccine (in the US) in healthy adults. The primary objective of the study was to demonstrate non-inferiority of Ixiaro to JE-Vax®[9] in terms of immunogenicity at day 56. Secondary objectives included the safety and local tolerability of both vaccines. Ixiaro was found to be highly immunogenic, resulting in protective antibody titers in 99% of subjects following two doses[4]. The immune response following vaccination with Ixiaro was sustained at six months, with 95% of the 181 subjects maintaining protective antibody titers. Eighty-three percent (83%) of subjects still maintained protective antibody levels after one year[7].
In addition, a multicenter, randomized, double-blind Phase III study was conducted in 2,675 healthy adults to assess the safety and tolerability of Ixiaro compared with placebo injections. Ixiaro was found to be well tolerated and no allergic reactions were observed. Ixiaro was found to have a similar safety profile to placebo and a statistically significantly better local tolerability profile than JE-Vax® [5],[6],[9].
About Ixiaro Vaccine
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. It provides a good immune response while being well tolerated. It does not contain thiomersal, gelatin or any other stabilizers or preservatives in its formulation. The vaccine is provided as a ready-to-use liquid formulation in pre-filled syringes and is administered in two doses 28 days apart.
On June 13, 2006, Novartis and Intercell announced that Novartis Vaccines had obtained worldwide marketing and distribution rights to the vaccine with the exception of Australia, Korea, Japan and certain other Asian markets. Ixiaro complements the Novartis Vaccines portfolio of travel vaccines which includes: Rabipur®/RabAvert® vaccine, protection against rabies; Typhoral L® vaccine, an oral typhoid vaccine and HAVpur® vaccine for the prevention of Hepatitis A.
About Japanese Encephalitis (JE)
Japanese Encephalitis (JE) disease is an acute inflammatory condition of the brain and spinal cord caused by the Japanese encephalitis virus (JEV). Most JE virus infections are mild (fever and headache) or without apparent symptoms, but approximately one in 300 infections results in severe disease characterized by rapid onset of high fever, headache, neck stiffness, disorientation, coma, seizures, spastic paralysis and death. The fatality rate is approximately 30% and as many as 50% of those who survive suffer from long term persistent neurological sequelae[2],[3]. In areas where the JE virus is common, encephalitis occurs mainly in young children because older children and adults are likely to have acquired natural immunity (through infection) or have been vaccinated. JE is a leading cause of viral encephalitis in Asia with 30,000 to 50,000 clinical cases reported annually[3].
Japanese encephalitis virus is only transmitted by certain types of mosquitoes (most commonly Culex tritaeniorhynchus). These mosquitoes are usually found in rural rice-growing areas of Asia, but can also be found at the outskirts of cities. The mosquitoes become infected by feeding on domestic pigs and wild birds that are infected with the Japanese encephalitis virus. Infected mosquitoes then transmit the Japanese encephalitis virus to other pigs and water birds and also to humans during feeding[8]. The nature of the JE life cycle means it is not possible to eradicate JE.
The transmission of JE is linked to the seasonality of the mosquitoes in these areas. JE is transmitted seasonally in large areas of Asia, but in some locations may be transmitted year round. Many areas with tropical climates hold a potential for year round transmission and, elsewhere, peak periods of increased viral transmission follows monsoon seasons and irrigation associated with rice cultivation. Approximately 3 billion people live in areas at risk of the disease. Novartis Vaccines is committed to educating travelers and healthcare providers about the risk of acquiring JE during travel and about protective modalities, including Ixiaro vaccine.
SOURCE: Novartis