FDA accepts BLA for meningococcal ABCWY vaccine, target action date set

The Biologics License Application (BLA) for GSK's 5-in-1 meningococcal ABCWY (MenABCWY) vaccine candidate has been accepted for review by the FDA, which assigned a Prescription Drug User Fee Action (PDUFA) date of February 14, 2025.¹

The combination vaccine targets 5 groups of the bacteria Neisseria meningitidis (A,B,C,W, AND Y) that cause the most invasive meningococcal disease cases (IMD) globally. The vaccine combines antigenic components of the meningococcal group B vaccine (Bexsero) and meningococcal groups A, C, Y, and W-135 Oligosaccharide Diphtheria CRM197 Conjugate Vaccine (Menveo).¹

The submission and acceptance of the BLA is based on a randomized, controlled, observer-blind, multi-country phase 3 trial (NCT04502693) that evaluated safety, tolerability, and immunogenicity of the vaccine candidate.¹

The trial enrolled approximately 3650 participants aged 10 to 25 years from the United States, Canada, Czech Republic, Estonia, Finland, Turkey, and Australia. The trial’s main objective was to assess immunological vaccine effectiveness against a panel of 110 MenB strains and to demonstrate non-inferiority of the immune responses of participants who received 2 doses of meningococcal ABCWY 6 months apart and compare responses to individuals who received 2 doses of meningococcal group B vaccine and 1 does of meningococcal groups A, C, Y, and W vaccine.¹

The trial met all primary endpoints and was “well tolerated with a safety profile consistent with both vaccines,” GSK stated in a press release.¹

“These statistically significant phase 3 data are a very encouraging step toward reducing the incidence of meningococcal disease. In the US, routine use of a 5-in-1 meningococcal vaccine with a two-dose regimen in adolescents at 16 to 18 years of age, just before this disease’s incidence peak, could drive significant public health impact,” GSK Chief Scientific Officer Tony Wood, PhD, said in a March 2023 statement.²

IMD can cause life-threatening complications and according to GSK, 1 in 6 individuals who contract IMD will die. One in 5 survivors could suffer long-term effects such as amputations, hearing loss, brain damage, and nervous system problems. Individuals in their late teens and early adulthood are higher risk groups.¹

MenB is the most common group of IMD-causing bacteria in US adolescents and young adults, making up more than half of the IMD cases in the age group in the United States from 2017 to 2021. GSK states less than 12% of adolescents in the United States have had the 2 required doses protection against MenB.¹

References:

1. GSK’s 5-in-1 meningococcal ABCWY vaccine candidate accepted for regulatory review by US FDA. GSK. Press release. April 16, 2024. Accessed April 16, 2024. https://www.gsk.com/en-gb/media/press-releases/gsk-s-5-in-1-meningococcal-abcwy-vaccine-candidate-accepted-for-regulatory-review-by-us-fda/
2. Meningococcal ABCWY vaccine meets primary endpoints in phase 3 trial. Contemporary Pediatrics. March 17, 2023. Accessed April 17, 2024. https://www.contemporarypediatrics.com/view/meningococcal-abcwy-vaccine-meets-primary-endpoints-in-phase-3-trial