US FDA Nod GSK's Gepotidacin NDA for Treating Urinary Tract Infections

GSK plc reported that the NDA for gepotidacin, a new oral antibiotic for treating female adults and adolescents with uUTIs, has been accepted by the US FDA. The FDA has decided to give Priority Review to this application and has set a PDUFA action date of March 26, 2025.

More than 50% of women will experience UTIs at some point in their lives, with around 30% dealing with recurring infections that can lead to considerable patient burden, such as discomfort and limitations in daily activities. There is a growing need for new treatments as the number of drug-resistant bacteria causing uUTIs is on the rise, leading to higher rates of treatment failure. Gepotidacin, a late-stage antibiotic in GSK's expanding infectious disease lineup, has the potential to be the inaugural oral antibiotic in a fresh category for uUTIs after more than two decades.

The NDA has received backing from the promising outcomes of the crucial phase III EAGLE-2 and EAGLE-3 clinical trials. In these trials, gepotidacin showed equivalence to nitrofurantoin, the established treatment for uUTI in women and adolescents with a confirmed uUTI and a uropathogen sensitive to nitrofurantoin. In the EAGLE-3 study, gepotidacin showed superior results compared to nitrofurantoin, with successful treatment in 58.5% of participants versus 43.6% for nitrofurantoin (difference of 14.6%, 95% CI (6.4, 22.8)). Gepotidacin showed efficacy in treating 50.6% of participants in EAGLE-2, compared to nitrofurantoin's 47.0%, with a treatment difference of 4.3% (95% CI (-3.6, 12.1)).