GSK Plc: NDA For Gepotidacin Granted Priority Review By FDA - Quick Facts

(RTTNews) - GSK plc (GSK, GSK.L) announced the FDA has accepted the New Drug Application for gepotidacin, an oral antibiotic with a mechanism of action for the treatment of female adults and adolescents with uncomplicated urinary tract infections. The FDA has granted Priority Review and assigned a PDUFA action date of 26 March 2025. The NDA is supported by positive results from the phase III EAGLE-2 and EAGLE-3 trials.

The development of gepotidacin has been funded in part with federal funds from the US Department of Health and Human Services, Administration for Strategic Preparedness and Response, and BARDA.

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