GSK plc said it plans to file a pentavalent vaccine candidate for meningococcal infections, MenABCWY, a combination of its on-market vaccines Bexsero and Menveo, for approval following a successful Phase III trial, the data from which were released on 14 March. First, however, GSK must file a supplemental biologic licensing application for full US approval of Bexsero.
GSK Tries To Chase Down Pfizer With Phase III Pentavalent Meningococcal Vaccine Data
Phase III data for a vaccine combining Bexsero and Menveo demonstrated non-inferiority. GSK hopes to file it for approval soon, while Pfizer’s candidate has an October FDA action date.
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