Novartis Files BLA to FDA For Men B Vaccine Bexsero

Novartis announced that it has filed a Biologic License Application (BLA) for Bexsero (Multicomponent Meningococcal Group B Vaccine [recombinant, adsorbed]) to the US Food and Drug Administration (FDA) for marketing approval.

Bexsero is a broad coverage vaccine developed for protection against meningitis B. Prior to Bexsero’s availability, only four of the five serogroups of meningococcus had effective vaccines for its treatment. Serogroup B was the last class of meningococcus to have a vaccine for its prevention. Bexsero has received approval in 34 countries around the world including the EU, Canada, and Australia.

The company’s application starts a rolling submission process for the vaccine to the FDA, which designated it as a Breakthrough Therapy in April 2014. The BLA seeks approval for the use of Bexsero in cases of invasive meningococcal disease caused by serogroup B (meningitis B) in adolescents and young adults from 10 to 25 years of age.

Andrin Oswald, Division Head of Novartis Vaccines, said, “Bexsero is the result of 20 years of groundbreaking research and a testament to our leadership in preventing rare but devastating diseases. 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.”

Meningococcal disease is a rare, deadly disease that can cause lifelong disability and death within the first 24 hours of onset of symptoms. With the disease’s aggressiveness and rapid progression, vaccination remains as the best defense against the disease.

The company has received an Investigational New Drug designation from the FDA allowing it to provide 30,000 Bexsero doses to staff and students at Princeton University and the University of California Santa Barbara (UCSB) after the explosion of meningitis B outbreaks in the areas. The US Centers for Disease Control and Prevention (CDC) have also recommended Bexsero administration to the incoming freshman class in the at-risk group at Princeton University.