FDA Grants Priority Review to GSK's New Antibiotic for UTIs

GSK’s application for its novel oral antibiotic, gepotidacin, has been accepted for priority review by the US Food and Drug Administration (FDA). This drug aims to address uncomplicated urinary tract infections (uUTIs). The FDA is anticipated to make a decision on this application by 26 March 2025, and if approved, gepotidacin would be the first new class of oral antibiotics for uUTIs in over two decades.

GSK is targeting gepotidacin for the treatment of uUTIs in female adults and adolescents aged 12 years and older who weigh at least 40 kilograms. The prevalence of uUTIs is significant, with more than half of women experiencing such infections at least once in their lifetime, and around 30% suffering from recurrent cases. The rise in uUTIs caused by drug-resistant bacteria highlights the urgent need for new therapeutic options.

Gepotidacin operates with a unique mechanism that targets most uropathogens, including E. coli and S. saprophyticus, even those strains resistant to existing antibiotics. The application for this drug is backed by successful outcomes from the EAGLE-2 and EAGLE-3 clinical trials. In these studies, gepotidacin showed non-inferiority compared to nitrofurantoin, the current standard treatment, in female patients with confirmed uUTIs caused by bacteria susceptible to nitrofurantoin.

The late-stage trials also demonstrated that the safety and tolerability of gepotidacin were consistent with earlier studies, reinforcing its potential as a viable treatment option. Addressing antimicrobial resistance (AMR) is critical since it poses one of the top ten global public health threats, according to the World Health Organization. AMR occurs when microorganisms evolve to resist antimicrobial drugs, making infections more challenging to treat and increasing the risk of severe health complications and mortality.

Earlier this year, GSK became the inaugural founding partner of the Fleming Initiative, a worldwide network dedicated to combating AMR. At the time of this announcement in May, GSK’s CEO, Emma Walmsley, emphasized the importance of this initiative, stating: “The Fleming Initiative will harness global resources and expertise across various sectors to enhance our understanding of the factors contributing to this rising threat and, crucially, to drive action and solutions. We are honored to be a founding partner and encourage others to join us in addressing this urgent priority.”