Posted by Michael Wonder on 17 Oct 2024
Gepotidacin accepted for priority review by US FDA for treatment of uncomplicated urinary tract infections in female adults and adolescents
16 October 2024 - Application supported by positive results from pivotal Phase 3 EAGLE-2 and EAGLE-3 trials.
GSK today announced that the US FDA has accepted the new frug application for gepotidacin, an investigational, first in class oral antibiotic with a novel mechanism of action for the treatment of female adults (≥40 kg) and adolescents (≥12 years, ≥40 kg) with uncomplicated urinary tract infections.
