Novartis seeks FDA approval for meningitis B vaccine

BASEL, Switzerland — Novartis on Tuesday announced that it had submitted a biologic license application to the Food and Drug Administration for marketing approval for the use of Bexsero. The vaccine will help combat invasive meningococcal disease caused by serogroup B (meningitis B) in adolescents and young adults from ages 10 years through 25 years, according to the company.



"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 United States has to endure the loss of a loved one from vaccine-preventable meningitis."



The vaccine is already approved in 34 countries. Since its launch in 2013, over half a million doses have been distributed. Last year, Novartis provided 30,000 doses of the vaccine to students and staff at Princeton University and the University of California Santa Barbara following campus-wide meningitis B outbreaks.