Approvals

GSK has announced that the US Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) forits5-in-1meningococcalABCWY (MenABCWY) vaccine candidate.

The drug has a Prescription Drug User Fee Act (PDUFA) action date for a regulatory decision by the FDA on the 14 February 2024.

The vaccine candidate ‘combines the antigenic components of its two well-established meningococcal vaccines with demonstrated efficacy and safety profiles, Bexsero (Meningococcal Group B Vaccine) and Menveo (Meningococcal [Groups A, C, Y, and W-135] Oligosaccharide Diphtheria CRM197 Conjugate Vaccine)’, according to the company’s press release. It will target the five groups of Neisseria meningitidis bacteria (Men A, B, C, W and Y) that cause the majority of invasive meningococcal disease (IMD) cases worldwide.

This combined vaccination is intended to merge the protection provided by the individual vaccines into fewer jabs, reducing the number of injections as well as simplifying the immunisation process. It is intended that it will also help to reduce the burden of IMD.

In a recent phase 3 trial, the vaccine candidate met all of its primary endpoints, including immunological non-inferiority to one dose of the existing meningococcal groups A, C, Y and W vaccine and non-inferior immune responses against 110 diverse MenB invasive strains, compared to two doses of an existing meningococcal group B vaccine. It was well tolerated with a safety profile consistent with the existing vaccines throughout the trial.

According to the press release, ‘In the US, while meningococcal vaccine recommendations for all five serogroups have been in place since 2015, annual immunisation rates for IMD have remained low overall, due in part to a complex schedule’, so it is hoped that this combined vaccine will help to combat this low uptake.