GSK announced that the US Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for late-stage gepotidacin.
The investigational oral antibiotic is intended to treat uncomplicated urinary tract infections (uUTIs) in adult and adolescent women.
FDA has granted Priority Review for this application. The Prescription Drug User Fee Act (PDUFA) action date is set for 26 March 2025.
GSK’s NDA is backed by positive results from the Phase 3 EAGLE-2 and EAGLE-3 trials.
EAGLE-2 and EAGLE-3 were non-inferiority trials that compared the efficacy and safety of gepotidacin and nitrofurantoin. The trials involved 1,531 and 1,605 female adults and adolescents, respectively.
Participants were followed for about 28 days. The primary endpoint was the combined clinical and microbiological response at the Test-of-Cure (ToC) visit for patients with qualifying uropathogens susceptible to nitrofurantoin.
In these studies, gepotidacin showed non-inferiority to nitrofurantoin, the current standard treatment for uUTIs in adult women and adolescents with confirmed infections.
In EAGLE-3, the antibiotic achieved statistical superiority, with therapeutic success in 58.5% of participants compared to 43.6% for nitrofurantoin.
In EAGLE-2, gepotidacin showed therapeutic success in 50.6% of participants, while nitrofurantoin had a success rate of 47.0%.
The safety and tolerability profile of the asset in both trials aligned with findings from previous studies.
EAGLE-1 trial evaluated the efficacy and safety of investigational antibiotic against ceftriaxone plus azithromycin in 628 patients with uncomplicated urogenital gonorrhea caused by Neisseria gonorrhoeae.
In a separate development, the British drugmaker announced that HIV company ViiV Healthcare has shared new real-world evidence on Apretude (cabotegravir long-acting) for HIV pre-exposure prophylaxis (PrEP).
ViiV Healthcare is majorly owned by GSK, with Pfizer and Shionogi as shareholders.
Findings from two real-world studies demonstrated over 99% effectiveness of CAB LA for PrEP in nearly 1,300 individuals.
Additionally, the PILLAR implementation study showed reduced stigma and anxiety among 200 individuals using this long-acting injectable PrEP option.
ViiV Healthcare chief medical officer Harmony Garges said: “The findings presented at IDWeek 2024 continue to support the strong and sustained effectiveness of Apretude for people in real life, outside the controlled environment of a clinical trial.
“The results of the studies from OPERA and Trio cohorts add to the growing body of evidence generated over the last three years, showing CAB LA for PrEP is a highly effective option for HIV prevention.”
