The US Food and Drug Administration (FDA) has approved a new antibiotic for treatment of uncomplicated urinary tract infections (uUTIs).
Developed by British drugmaker GSK in collaboration with the US government's Biomedical Advanced Research and Development Authority, gepotidacin is a first-in-class triazaacenaphtylene antibiotic that uses a distinct mechanism of action to inhibit bacterial replication. The FDA approved it 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.
An estimated 50% of all women globally have at least one uUTI in their lifetime, including 16 million women annually in the United States, and resistance to existing antibiotic treatments has been rising, resulting in increasing incidence of recurrent infections. Gepotidacin, which will be marketed under the brand name Blujepa, is the first in a new class of oral antibiotic for uUTIs in nearly 30 years.
"The approval of Blujepa is a crucial milestone with uUTIs among the most common infections in women," GSK Chief Scientific Officer Tony Wood, PhD, said yesterday in a company press release.
Antibiotic could offer 'substantial benefits' to patients
The approval was based on the results of the 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. Both trials, which involved more than 3,000 patients in 12 countries, were stopped early after a pre-specified interim analysis found that gepotidacin met the combined efficacy end points.
In EAGLE-2, gepotidacin demonstrated noninferiority in therapeutic success to nitrofurantoin. In EAGLE-3, analysis of therapeutic success found that gepotidacin was statistically superior to nitrofurantoin. Safety and tolerability were consistent with previous trials.
"As a first-in-class investigational oral antibiotic with activity against common uropathogens, including clinically important drug-resistant phenotypes, gepotidacin has the potential to offer substantial benefit to patients," trial investigators wrote in The Lancet in February 2024.
GSK says the commercial launch of gepotidacin is planned for later this year. The company is also investigating gepotidacin as a potential option for uncomplicated gonorrhea. GSK officials announced last February that preliminary results from another phase 3 trial (EAGLE-1) showed gepotidacin was noninferior to the current standard-of-care gonorrhea treatment (intramuscular ceftriaxone plus oral azithromycin) in patients with uncomplicated urogenital gonorrhea.
