The U.S. Food and Drug Administration (FDA) has approved a groundbreaking new oral antibiotic, gepotidacin (marketed under the brand name Blujepa), developed by British drugmaker GSK, to treat uncomplicated urinary tract infections (uUTIs) – the first new class of oral antibiotic for this indication in nearly 30 years.
The FDA approved Blujepa for women and children 12 years and older with uUTIs caused by susceptible organisms, including Escherichia coli, Klebsiella pneumoniae, Citrobacter freundii complex, Staphylococcus saprophyticus, and Enterococcus faecalis.
Gepotidacin is a first-in-class triazaacenaphtylene antibiotic that employs a distinct mechanism of action to inhibit bacterial replication, offering a lower potential for drug resistance than existing treatments.
The approval was based on results from two Phase 3 randomized controlled trials (EAGLE-2 and EAGLE-3) that compared the safety and efficacy of gepotidacin with nitrofurantoin, one of the first-line treatments for uUTIs that was introduced in the 1950s.
In EAGLE-2, gepotidacin demonstrated noninferiority in therapeutic success to nitrofurantoin, with 50.6% of participants achieving therapeutic success compared to 47% on nitrofurantoin.
In EAGLE-3, analysis of therapeutic success found that gepotidacin was statistically superior to nitrofurantoin, with 58.5% of those on Blujepa achieving therapeutic success versus 43.6% on nitrofurantoin.
GSK says the commercial launch of gepotidacin is planned for the second half of 2025, though the company has not revealed any pricing information yet.
Dosing of Blujepa is two pills taken twice daily for five days, with the most common side effects being diarrhea (16% of trial participants) and nausea (9%), though these side effects were mostly mild.
The development of gepotidacin was funded in part by the U.S. government’s Biomedical Advanced Research and Development Authority, marking collaboration between pharmaceutical and government entities to address drug-resistant infections.
This approval addresses rising drug resistance in urinary tract infections, with millions of women experiencing painful UTIs that keep coming back, and represents one of five new endorsements anticipated by GSK this year.
