How gepotidacin offers new option for uncomplicated UTIs, with Ryan Haumschild, PharmD

The recent approval of gepotidacin marks a significant advancement in the treatment of uncomplicated urinary tract infections (uUTIs) in female adults and adolescents, offering an alternative to existing antibiotics that have been in use for decades.

Ryan Haumschild, PharmD, MS, MBA, CPEL, vice president of pharmacy at Emory Healthcare and Winship Cancer Institute, highlighted the importance of this approval. "I think the value for uncomplicated UTIs is still really high, right? Because we have therapies that we can utilize, such as nitrofurantoin or fluoroquinolones, but at the same time, we've utilized those for a little while, and so individuals' antibiograms might show some type of resistance," he said.

Gepotidacin, developed by GSK, is the first in a new class of oral antibiotics for uUTIs in over 20 years. Its approval is based on positive results from the Phase III EAGLE-2 and EAGLE-3 trials, where it demonstrated non-inferiority to nitrofurantoin, a standard treatment for uUTIs. In one of the trials, gepotidacin even showed statistically significant superiority, with a therapeutic success rate of 58.5% compared to 43.6% for nitrofurantoin.

With concerns about rising antibiotic resistance, gepotidacin’s novel mechanism of action is particularly valuable. "Now, when we look at the clinical trial data, it was non-inferior to current available treatment options, which isn't a bad thing... because now it shows that there is equitable data that gives another option," Haumschild explained. "A lot of times in the antibiotics, yes, you're looking for superiority, but a lot of times, what's another option that will really impede the resistance that we're seeing across the board?"

The new treatment is expected to provide a safer alternative for patients who experience side effects from existing antibiotics. "How can we use this new option that might have a different side effect profile and leverage that for specific patient populations, then we can decrease resistance?" Haumschild noted.

Reference:

GSK. Gepotidacin accepted for priority review by US FDA for treatment of uncomplicated urinary tract infections in female adults and adolescents. GSK. October 16, 2024. Accessed March 25, 2025. https://www.gsk.com/en-gb/media/press-releases/gepotidacin-accepted-for-priority-review-by-us-fda-for-treatment-of-uncomplicated-urinary-tract-infections-in-female-adults-and-adolescents/