Biopharmaceutical company GSK PLC (LSE: GSK) (NYSE: GSK) announced on Wednesday that the US Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for gepotidacin, an investigational oral antibiotic aimed at treating uncomplicated urinary tract infections (uUTIs) in female adults and adolescents. The application has been granted Priority Review status, with a Prescription Drug User Fee Act (PDUFA) action date set for 26 March 2025.

Gepotidacin has the potential to be the first new class of oral antibiotics for uUTIs in over 20 years, addressing an urgent need as drug-resistant bacteria increasingly contribute to treatment failures. The NDA is backed by positive outcomes from pivotal phase III trials, EAGLE-2 and EAGLE-3, where gepotidacin showed non-inferiority and, in some instances, superiority to nitrofurantoin, the current standard treatment.

The trials involved over 3,100 female participants, with gepotidacin achieving therapeutic success rates of 50.6% to 58.5% compared to 43.6% for nitrofurantoin. The safety profile was consistent with prior studies, predominantly reporting gastrointestinal adverse events.

Gepotidacin represents a significant advancement in GSK's infectious disease portfolio, which is supported by federal funding from the US Department of Health and Human Services. GSK continues to develop innovative solutions to combat antimicrobial resistance, enhancing its diverse pipeline of medicines and vaccines.