GSK plc, trading as GSK and on the London Stock Exchange as GSK.L, has announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application for gepotidacin. This oral antibiotic, which has a unique mechanism of action, is intended for the treatment of uncomplicated urinary tract infections in female adults and adolescents. The FDA has granted this application Priority Review status and has set a Prescription Drug User Fee Act (PDUFA) target decision date for March 26, 2025. The application is backed by favorable outcomes from the phase III EAGLE-2 and EAGLE-3 clinical trials.
The development of gepotidacin has received partial funding from federal sources, specifically the U.S. Department of Health and Human Services' Administration for Strategic Preparedness and Response and the Biomedical Advanced Research and Development Authority (BARDA).
