FDA Approves Gepotidacin for Uncomplicated UTI
The decision makes the therapy the first oral antibiotic treatment approved for uUTIs in over 20 years.
The FDA has approved gepotidacin (Blujepa) for the treatment of uncomplicated urinary tract infections (uUTIs) in female patients aged 12 years or older who weigh at least 40 kilograms, GSK announced in a release.1 The decision makes the therapy the first oral antibiotic treatment approved for uUTIs in over 20 years.
FDA Approves Gepotidacin for Uncomplicated UTI / Grandbrothers - stock.adobe.com
Gepotidacin is a first-in-class triazaacenaphthylene antibiotic that works by inhibiting bacterial DNA replication at a distinct binding site. Because the therapy inhibits 2 Type II topoisomerase enzymes, it’s expected to have a lower potential for resistance development. Gepotidacin was approved to treat uUTIs caused by microorganisms Citrobacter freundii complex, Escherichia coli, Klebsiella pneumoniae, Staphylococcus saprophyticus and Enterococcus faecalis.
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“For many, uUTIs can be a burden that severely impacts daily life,” Thomas Hooton, MD, professor of clinical medicine at the University of Miami School of Medicine, said in a release.1 “With an increasing number of patients experiencing recurrent infections, there remains a clear need for continued research of antimicrobials to help address ongoing patient challenges and the strain on healthcare systems.”
The approval of gepotidacin was based on data from the EAGLE 2 (NCT04020341) and EAGLE 3 (NCT04187144) clinical trials. Both trials were randomized, multicenter, parallel-group, double-blind, double-dummy phase 3 studies evaluating the efficacy and safety of gepotidacin versus nitrofurantoin in adolescent and adult female patients with uUTIs. While the trials were similar, EAGLE-2 provided additional pharmacokinetic data and EAGLE-3 included an electrocardiogram test.
The study cohorts included 1531 patients in EAGLE 2 and 1606 in EAGLE 3. The patients received either gepotidacin 1500 mg or nitrofurantoin 100 mg twice daily day for 5 days up to day 28. Patients were included in the study if they had 2 or more clinical signs of uUTI with onset 96 hours or less prior to entering the study. Exclusion criteria included residing in a nursing home, having uncontrolled high blood pressure or diabetes, having a history of sensitivity to the study drugs, and being immunocompromised.
The studies found that gepotidacin demonstrated non-inferiority to nitrofurantoin. The therapy demonstrated therapeutic success in 58.5% of patients, compared to 43.6% for nitrofurantoin in EAGLE 3. In EAGLE 2, gepotidacin demonstrated therapeutic success in 50.6% of patients, versus 47% for nitrofurantoin.2
Additionally, the safety and tolerability of gepotidacin was consistent with previous trials. The most commonly reported adverse events were gastrointestinal symptoms, including diarrhea and nausea. Most adverse events were seen to be either mild or moderate in severity, with 1 serious drug-related adverse event occurring in each group.
GSK said in the release that it expects to launch gepotidacin commercially in the United States in the second half of 2025.
“The approval of Blujepa is a crucial milestone with uUTIs among the most common infections in women,” Tony Wood, chief scientific officer at GSK, said in a release.1 “We are proud to have developed Blujepa, the first in a new class of oral antibiotics for uUTIs in nearly three decades, and to bring another option to patients given recurrent infections and rising rates of resistance to existing treatments.”
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