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.
The pharma was not specific on timing, but its candidate is already behind Pfizer Inc.’s pentavalent meningococcal vaccine, which has an October action date at the US Food and Drug Administration
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