Corporate Banner
Satellite Banner
Immunology
Scientific Community
 
Become a Member | Sign in
Home>News>This Article
  News
Return

Intercell Receives CHMP Positive Opinion for the Pediatric Indication of IXIARO®

Published: Thursday, December 20, 2012
Last Updated: Wednesday, December 19, 2012
Bookmark and Share
Final approval is expected in February or March 2013.

Intercell AG has announced that the CHMP of the European Medicines Agency (EMA) has come to a positive opinion on the Marketing Authorization for IXIARO® in children, a vaccine to protect against Japanese Encephalitis (JE).

The final decision (approval) by the European Commission is expected in February or March 2013.

Intercell has submitted applications for the approval of a JE vaccine pediatric label extension to major regulatory agencies in late Q2 2012 based on data from a Phase III clinical study conducted in the Philippines and favorable interim data from a second Phase III trial in EU, US and Australia.

In both studies the JE vaccine showed to be highly immunogenic in children aged 2 months to <18 years with a safety profile comparable to pediatric vaccines licensed for other diseases.

“We are very pleased about the positive CHMP opinion on the pediatric indication for our JE vaccine. This will be the first time European travelers of all ages can be protected against this dreadful disease with a licensed vaccine", states Thomas Lingelbach, Chief Executive Officer of Intercell AG.

Following the approval and launch of Intercell's vaccine against Japanese Encephalitis for adult travelers and military personnel in Europe, the United States, Canada, Hong Kong, Singapore, Israel (IXIARO®) and Australia and New Zealand (JESPECT®), the development of a vaccine to protect children traveling to endemic areas from Japanese Encephalitis has been a major goal of the Company.

The vaccine to prevent Japanese Encephalitis (JE) is Intercell’s first product on the market. This is a next-generation vaccine used to help prevent infection with the JE virus, and has been licensed in more than 30 countries.

The vaccine is a purified, inactivated vaccine and causes the body to produce its own protection (antibodies) against this disease.

Upon approval of the new indication for the pediatric age segment in the EU, the vaccine will offer protection against JE for adults and children aged 2 months and above who travel to, or live in, endemic areas.

In the U.S. the vaccine is currently licensed for those above 17 years of age, and in Canada, Australia and New Zealand it is licensed for persons above 18 years of age.

In the U.S. the pediatric label extension is currently under review by the FDA.

The vaccine is manufactured by Intercell AG’s wholly-owned subsidiary Intercell Biomedical Ltd. at our cGMP facility in Livingston, Scotland.


Further Information

Join For Free

Access to this exclusive content is for Technology Networks Premium members only.

Join Technology Networks Premium for free access to:

  • Exclusive articles
  • Presentations from international conferences
  • Over 3,500+ scientific posters on ePosters
  • More than 5,000+ scientific videos on LabTube
  • 35 community eNewsletters


Sign In



Forgotten your details? Click Here
If you are not a member you can join here

*Please note: By logging into TechnologyNetworks.com you agree to accept the use of cookies. To find out more about the cookies we use and how to delete them, see our privacy policy.

Related Content

Thomas Szucs Elected New Chairman of Intercell’s Supervisory Board
Thomas Szucs takes over the function from Michel Gréco, who resigned from the role but still remains a member of the Supervisory Board.
Tuesday, January 03, 2012
Scientific News
Iron Nanoparticles Make Immune Cells Attack Cancer
Researchers accidentally discover that nanoparticles invented for anemia treatment can trigger the immune system’s ability to destroy tumor cells.
Uncovering Cancer’s ‘Invisibility Cloak’
Researchers discover cancer cell mechanism to become invisible to the body's immune system.
Treating Sepsis with Marine Mitochondria
Mitochondrial alternative oxidase from a marine animal combats bacterial sepsis.
Culex Mosquitoes Do Not Transmit Zika
A study of the Culex species mosquito appears to show that the species does not transmit Zika virus.
Bacteria Use Ranking Strategy to Fight Off Viruses
Researchers have explained why microbes store virus confrontation information sequentially, with most recent attacks first.
Molecular Switch Aids Immune Therapy
Researchers identify strategy to maximise effectiveness of immune therapy through molecular switch controlling immune suppression.
Reprogramming Lymph Nodes to Fight MS
Bioengineers work to reprogram lymph node function to fight multiple sclerosis.
Antibodies Block Norovirus’ Entrance into Cells
Scientists have uncovered a mechanism in the human body that targets and successfully blocks noroviruses.
Probe Detects Histone Modifications in Cells
Scientists have developed an antibody probe that can be used to monitor the dynamics of histone modification.
Gut Pathogens Thrive on Body's Tissue-Repair Mechanism
Researcher have discovered that harm caused by pathogens in the intestinal tract benefit from immune system response to damaged intestinal lining.
Skyscraper Banner

SELECTBIO Market Reports
Go to LabTube
Go to eposters
 
Access to the latest scientific news
Exclusive articles
Upload and share your posters on ePosters
Latest presentations and webinars
View a library of 1,800+ scientific and medical posters
3,500+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
5,000+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!