Novartis submits application to the FDA for meningitis B vaccine candidate Bexsero® to help protect US adolescents and young adults

• Submission follows receipt of Breakthrough Therapy designation in April 2014, highlighting unmet need for a licensed vaccine for serogroup B in the US¹
  
• Meningitis B is a rare but aggressive disease that can kill or cause serious life-long disability within 24 hours of onset, often with initial flu-like symptoms^2,3,4
  
• Bexsero, approved in 34 countries, was recently provided to two US universities under an Investigational New Drug designation in response to outbreaks^5,6,7,8,9,10

Novartis announced today the submission of a Biologic License Application (BLA) to the US Food and Drug Administration (FDA) for marketing approval for the use of Bexsero^® (Multicomponent Meningococcal Group B Vaccine [recombinant, adsorbed]) to help protect against invasive meningococcal disease caused by serogroup B (meningitis B) in adolescents and young adults from 10 years through 25 years of age. This submission initiates a rolling submission process for Bexsero to the FDA, following the receipt of a Breakthrough Therapy designation in April.

“Bexsero is the result of 20 years of groundbreaking research and a testament to our leadership in preventing rare but devastating diseases,” said Andrin Oswald, Division Head, Novartis Vaccines. “With today’s submission, we are one step closer to ensuring that no family in the US has to endure the loss of a loved one from vaccine-preventable meningitis.”

Bexsero is the first broad coverage vaccine to help protect against meningitis B¹¹. The vaccine is already approved in 34 countries including across the European Union, Canada and Australia^5,6,7,8. Since the launch of Bexsero in 2013, over half a million doses have been distributed worldwide¹².

In the US, Novartis has provided nearly 30,000 doses of Bexsero to students and staff at Princeton University and the University of California Santa Barbara (UCSB) following meningitis B outbreaks on their campuses under an Investigational New Drug (IND) designation from the FDA^9,10,12. Further, the US Centers for Disease Control and Prevention (CDC) have recommended including the incoming freshman class at Princeton University in the at-risk group to receive Bexsero¹³.

Meningococcal disease can be easily misdiagnosed and while rare, it can have serious consequences, including lifelong disability and death within the first 24 hours of symptom onset^2,3,4. It is most commonly caused by one of the five main serogroups of meningococcal bacteria (A, B, C, W-135 and Y)¹⁴. Prior to the development of Bexsero, vaccines were only available for four of the five serogroups of the meningococcus, and a vaccine to protect against serogroup B was the remaining piece needed to provide populations with broad-spectrum protection against these serogroups that together cause the majority of cases in the world^14,15.

Novartis is committed to working with US health authorities to help provide access to Bexsero for all at-risk groups. Meningococcal disease can have tremendous impact on individuals and their families. Vaccination is the best defense against a disease that can be aggressive, and leave little time for intervention.

References

1.  Centers for Disease Control and Prevention. Epidemiology and Prevention of Vaccine-Preventable Diseases (The Pink Book: Course Textbook). 12th Edition, 2nd printing. May 2012 update. Available at: http://www.cdc.gov/vaccines/pubs/pinkbook/mening.html. Accessed June 2014.
2. KidsHealth.org. Meningitis. Available at: http://kidshealth.org/parent/infections/lung/meningitis.html. Accessed June 2014.
3. National Meningitis Association. “What are the Symptoms?” Available at: http://www.nmaus.org/disease-prevention-information/what-are-the-symptoms. Accessed June 2014.
4. World Health Organization. Meningococcal meningitis fact sheet. Available at: http://www.who.int/mediacentre/factsheets/fs141/en/index.html. Accessed June 2014.
5. European Medicines Agency. Authorization Details for Bexsero. Available at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/002333/human_med_001614.jsp&mid=WC0b01ac058001d124. Accessed June 2014.
6. European Medicines Agency. EU Member States. Available at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/partners_and_networks/general/general_content_000219.jsp&mid=WC0b01ac058003174e. Accessed June 2014.
7. Health Canada. Bexsero. Available at: http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/drug-med/sbd_smd_2014_bexsero_147275-eng.php. Accessed June 2014.
8. Australian Government: Department of Health: Therapeutic Goods Administration. Available at: http://www.tga.gov.au/pdf/auspar/auspar-meningococcal-131031.pdf. Accessed June 2014.
9. Centers for Disease Control and Prevention. Princeton University Meningococcal Disease Outbreak. December 2013. Available at: http://www.cdc.gov/meningococcal/outbreaks/princeton.html. Accessed June 2014.
10. Centers for Disease Control and Prevention. University of California, Santa Barbara Meningococcal Disease Outbreak. January 2014. Available at: http://www.cdc.gov/meningococcal/outbreaks/ucsb.html. Accessed June 2014.
11. Perrett KP, Pollard AJ. Towards an improved serogroup B Neisseria meningitidis vaccine. Expert Opinion on Biological Therapy. 2005;5:1611-1625. Available at: http://informahealthcare.com/doi/abs/10.1517/14712598.5.12.1611. Accessed June 2014.
12. Novartis data on file.
13. Princeton University. Emergency Guidelines for the Campus Community. Meningitis Information for Admitted Students. http://web.princeton.edu/sites/emergency/meningitis/FAQ-Admitted.html. Accessed June 2014.
14. Immunization Action Coalition. Meningitis: Questions & Answers. Available at: http://www.immunize.org/catg.d/p4210.pdf. Accessed June 2014.
15. Harrison LH. Prospects for vaccine prevention of meningococcal infection. Clinical Microbiology Reviews. 2006; 19(1):142-1643. Available at: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1360272/. Accessed June 2014.