Novartis files for US approval of meningitis B vaccine Bexsero

Swiss pharma major Novartis (NOVN: VX) has submitted a Biologic License Application to the US Food and Drug Administration 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, the company noted.

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