Novartis seeks FDA approval for meningitis B vaccine, Bexsero

Basel, June 17, 2014 – 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.

Neisseria meningitidis
Image/CDC

“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 B. The vaccine is already approved in 34 countries including across the European Union, Canada and Australia. Since the launch of Bexsero in 2013, over half a million doses have been distributed worldwide.

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. 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 Bexsero.

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. It is most commonly caused by one of the five main serogroups of meningococcal bacteria (A, B, C, W-135 and Y). 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.

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.