GSK BLA Accepted for Meningococcal Vaccine

FDA has accepted for review a GSK BLA for its 5-in-1 meningococcal ABCWY (MenABCWY) vaccine candidate. The user fee review action target date is 2/14/2025.

The vaccine combines the antigenic components of the company’s two established meningococcal vaccines — Bexsero (meningococcal Group B vaccine) and Menveo (meningococcal [Groups A, C, Y, and W-135] oligosaccharide diphtheria vaccine), GSK says. It is intended to target the five groups of the bacteria Neisseria meningitidis (Men A, B, C, W, and Y) that cause most invasive meningococcal disease cases globally.

The submission is based on data from the a Phase 3 trial (NCT04502693) that met all primary endpoints, including immunological non-inferiority to one dose of GSK’s Meningococcal Groups A,C,Y and W Vaccine, and non-inferior immune responses against 110 diverse MenB invasive strains (representing 95% of MenB strains circulating in the U.S.) as compared to two doses of GSK’s Meningococcal Group B Vaccine, the company says.