GSK: vaccine accepted for FDA review

(CercleFinance.com) - GSK announces that the US FDA has accepted for review a Biologics License Application (BLA) for its 5-in-1 meningococcal ABCWY vaccine candidate (MenABCWY).


The Prescription Drug User Fee Act (PDUFA) action date for a US FDA regulatory decision on this application is 14 February 2025.

This submission is based on results from the pivotal Phase III trial showing that all primary endpoints were met.

The vaccine candidate offers broad coverage against the five most common bacterial groups causing invasive meningococcal disease, and could reduce the number of injections to simplify vaccination, if approved.

The combination of protection offered by these vaccines in fewer injections aims to reduce the number of injections, simplifying vaccination. This may help increase series completion and vaccination coverage, and reduce the overall burden of IMD, as unvaccinated adolescents are particularly at risk of infection and potential epidemics, the group says.


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