Novartis’ meningitis B vaccine Bexsero approved by US FDA

On Friday, the US Food and Drug Administration granted accelerated approval of Swiss pharma giant Novartis’ (NOVN: VX) Bexsero (Meningococcal Group B Vaccine [recombinant, adsorbed]) for active immunization to prevent invasive meningococcal disease caused by serogroup B (also known as meningitis B) in adolescents and young adults from 10 years through 25 years of age.

Bexsero is the only meningitis B vaccine approved in the USA with a two-dose regimen and a flexible dosing schedule. As part of the accelerated approval process, Novartis will complete its ongoing studies to confirm the effectiveness of Bexsero against diverse serogroup B strains. Bexsero received a Breakthrough Therapy designation from the FDA last year.

Bexsero is the second vaccine cleared by the FDA in the past three months to prevent this disease. The agency approved the first meningococcal serogroup B vaccine, US pharma major Pfizer’s (NYSE: PFE) Trumenba (meningococcal group B vaccine), last year. Before these approvals, existing approved meningococcal vaccines in the USA covered only four of the five main serogroups of N. meningitidis bacteria that cause meningococcal disease: A, C, Y and W. The US Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP) is expected to make its first recommendation for use of serogroup B vaccines in February 2015.