GSK’s new drug application for its investigational oral antibiotic gepotidacin has been accepted for priority review by the US Food and Drug Administration (FDA) to treat uncomplicated urinary tract infections (uUTIs).
The regulator is expected to make a decision on gepotidacin, which could be the first in a new class of oral antibiotics for uUTIs in over 20 years, by 26 March 2025.
GSK is specifically seeking approval of the drug to treat female adults and adolescents aged 12 years and older and weighing at least 40kg.
More than half of women are affected by uUTIs in their lifetime, with approximately 30% experiencing recurrent disease. Additionally, the number of uUTIs caused by drug-resistant bacteria is increasing, underscoring the need for new treatment options.
Gepotidacin’s distinct mechanism of action provides activity against most target uropathogens, such as E. coli and S. saprophyticus, including isolates resistant to current antibiotics.
GSK’s application for the drug is supported by positive results from the late-stage EAGLE-2 and EAGLE-3 trials, in which gepotidacin demonstrated non-inferiority to nitrofurantoin, the current standard of care, in female adults and adolescents with a confirmed uUTI and a uropathogen susceptible to nitrofurantoin.
The safety and tolerability profile of gepotidacin in the EAGLE-2 and EAGLE-3 was also shown to be consistent with previous trials of the drug.
Designated by the World Health Organization as one of the top ten threats to global public health, AMR occurs when bacteria, viruses, fungi and parasites change and find ways to resist the effects of antimicrobial drugs. As a result, infections become harder to treat and the risk of serious complications and death increases.
GSK became the first founding partner of the Fleming Initiative, a new global network aimed at tackling AMR, earlier this year.
The company’s chief executive officer, Emma Walmsley, said at the time of the May announcement: “The Fleming Initiative will bring together global resources and expertise from across different sectors to better understand the factors contributing to this growing threat and, most importantly, drive action and solutions. We are proud to be a founding partner and hope others will join us to support this urgent priority.”