BRIEF—GSK’s 5-in-1 meningococcal ABCWY vaccine BLA accepted by FDA

UK pharma major GSK says that the US Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for its 5-in-1 meningococcal ABCWY (MenABCWY) vaccine candidate.

The Prescription Drug User Fee Act (PDUFA) date for a regulatory decision is February 14, 2025.

The vaccine candidate provides broad coverage against the five most common groups of bacteria causing invasive meningococcal disease and could reduce number of injections to simplify immunization, if approved, GSK noted.

The BLA submission was based on  results from the pivotal phase III trial showing all primary endpoints were met.

In the USA, while meningococcal vaccine recommendations for all five serogroups have been in place since 2015, annual immunization rates for invasive meningococcal disease IMD have remained low overall, due in part to a complex schedule.