GSK announces U.S. FDA accepted NDA for gepotidacin

GSK announced the US Food and Drug Administration, FDA, has accepted the New Drug Application, NDA, for gepotidacin, an investigational, first-in-class oral antibiotic with a novel mechanism of action for the treatment of female adults and adolescents with uncomplicated urinary tract infections, uUTIs. The FDA has granted Priority Review for this application and assigned a Prescription Drug User Fee Act, PDUFA, action date of 26 March 2025. The NDA is supported by results from the phase III EAGLE-2 and EAGLE-3 trials. In these studies, gepotidacin demonstrated non-inferiority to nitrofurantoin, the current standard of care for uUTI, in female adults and adolescents with a confirmed uUTI and a uropathogen susceptible to nitrofurantoin.