FDA Accepts GSK's 5-in-1 Meningococcal ABCWY Vaccine Candidate For Regulatory Review

(RTTNews) - The U.S. Food and Drug Administration has accepted for review a Biologics License Application or BLA for GSK plc.'s (GSK, GSK.L) 5-in-1 meningococcal ABCWY (MenABCWY) vaccine candidate, the company said in a statement on Tuesday.

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

GSK's 5-in-1 MenABCWY vaccine candidate combines the antigenic components of its two well-established meningococcal vaccines with demonstrated efficacy and safety profiles, Bexsero and Menveo.

GSK stated that 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 immunisation, if approved.

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