GSK’s New Antibiotic for Uncomplicated Urinary Tract Infections Gets Priority Review from FDA
The FDA has granted Priority Review to GSK plc’s marketing application for gepotidacin, an investigational oral antibiotic designed to treat uncomplicated urinary tract infections (uUTIs) in adult and adolescent females. This signifies a significant step forward in the fight against uUTIs, which affect over half of all women during their lifetime, with a significant portion experiencing recurrent infections.
The rising incidence of drug-resistant bacteria causing uUTIs has led to increased treatment failure rates, making the development of new treatment options crucial. Gepotidacin, a late-stage antibiotic within GSK’s expanding infectious disease portfolio, has the potential to be the first new class of oral antibiotics for uUTIs in over two decades.
The FDA’s decision to grant Priority Review, with a Prescription Drug User Fee Act (PDUFA) action date set for March 26, 2025, highlights the importance of this potential treatment. The application is backed by data from the phase 3 EAGLE-2 and EAGLE-3 clinical trials, which demonstrated gepotidacin’s non-inferiority to nitrofurantoin, the current standard of care for uUTIs.
In fact, gepotidacin achieved statistically significant superiority over nitrofurantoin in the EAGLE-3 trial, with therapeutic success rates of 58.5% compared to 43.6% for nitrofurantoin. The EAGLE-2 trial also showed promising results, with gepotidacin demonstrating therapeutic success in 50.6% of participants compared to 47.0% for nitrofurantoin.
The development of gepotidacin has been supported by federal funds from the U.S. Department of Health and Human Services, Administration for Strategic Preparedness and Response, Biomedical Advanced Research and Development Authority (BARDA).
GSK’s stock has seen a positive response to this news, rising by 0.40% to $39.12 at the close of trading on Wednesday.