Gepotidacin NDA Under Priority Review by FDA for Uncomplicated UTI
Gepotidacin is a first-in-class oral antibiotic with a novel mechanism of action.
The FDA has accepted the New Drug Application (NDA) for investigational, first-in-class oral antibiotic gepotidacin, according to a press release from manufacturer GSK. The drug, which has a novel mechanism of action, is intended to treat women and adolescent girls with uncomplicated urinary tract infections (UTI).1
The NDA for gepotidacin has been gratned priority review by the FDA, and has a PDUFA date of March 26, 2025.
Gepotidacin is a first-in-class antibiotic for uncomplciated UTI. | image credit: nuengneng - stock.adobe.com
The application is supported by data from the 2 pivotal phase 3 clinical trials: EAGLE-2 and EAGLE-3 (NCT04020341; NCT04187144). These studies evaluated the drug in a cohort of women (n=1531) and adolescent girls (n=1605) with uncompcliated UTIs susceptible to nitrofurantoin, who received either 1500 mg oral gepotidacin or 100 mg oral nitrofurantoin twice daily for 5 days.
Gepotidacin demonstrated noninferiority to nitrofurantoin, which is the current standard of care in uncomplicated UTI. In the EAGLE-3 study, the drug achieved statistically significant superiority vs nitrofurantoin, with therapeutic success in 58.5% of 277 participants (vs 43.6% of 264 participants in the nitrofurantoin group), representing a treatment difference of 14.6% (95% CI, 6.4-22.8). In EAGLE-2, therapeutic success was demonstrated in 50.6% of 320 participants who received gepotidacin vs 47% of 287 who received nitrofurantoin (treatment difference, 4.3%; 95% CI, -3.6 to 12.1).
Across both trials, safety and tolerability profiles remained with previous clinical research. The most commonly reported adverse events were gastrointestinal in nature, including diarrhea and nausea, in 16% and 9% of participants, respectively; a majority of these events were mild or moderate.
READ MORE: FDA Accepts Bayer’s NDA for Elinzanetant to Treat Menopause Symptoms
Gepotidacin is a first-in-class investigational bactericidal triazaacenaphthylene antibiotic with a novel mechanism of action that “provides well-balanced inhibition of 2 different Type II topoisomerase enzymes,” including most target uropathogens, such as Eschera coli and Staphylococcus saprophyticus. Gepotidacin also targets Neisseria gonorrhoeae and is being evaluated vs ceftriaxone plus azithromycin for urogenital gonorrhea in the EAGLE-1 clinical trial (NCT04010539).
Over half of all women experience an uncomplicated UTI during their lifetime; approximately 30% of those experience recurrent disease, which creates significant patient burden. As the number of uncomplicated UTIs due to drug-resistant bacteria increases, the development of new treatments is crucial.
READ MORE: Women’s Health Resource Center
