FDA Approves GSK’s Blujepa for Uncomplicated Urinary Tract Infections

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The FDA has approved GSK’s Blujepa (gepotidacin), a first-in-class oral antibiotic for the treatment of uncomplicated urinary tract infections (uUTIs) in female adults and patients over 12 years of age. According to the company, Blujepa introduces a novel mechanism of action, marking the first new oral antibiotic for uUTIs in almost 30 years.¹

“The approval of Blujepa is a crucial milestone with uUTIs among the most common infections in women,” said Tony Wood, chief scientific officer, GSK, in a press release. “We are proud to have developed Blujepa, the first in a new class of oral antibiotics for uUTIs in nearly three decades, and to bring another option to patients given recurrent infections and rising rates of resistance to existing treatments.”

Approval was based on results from the Phase III randomized, multicenter, double-blind, double-dummy, non-inferiority EAGLE-2 and EAGLE-3 trials, which evaluated the efficacy and safety of Blujepa. In the trials, 1,531 patients in EAGLE-2 and 1,605 patients in EAGLE-3 were randomly assigned in a 1:1 ratio to receive either Blujepa at a dose of 1,500 mg twice daily or nitrofurantoin at a dose of 100 mg twice daily. The primary endpoint of the studies was therapeutic response at test-of-cure (day 10–13) in patients with bacteria susceptible to nitrofurantoin.^1,2

EAGLE-2 confirmed that Blujepa was non-inferior to nitrofurantoin, with therapeutic success in 50.6% of patients administered Blujepa compared to 47% in the nitrofurantoin group. In EAGLE-3, Blujepa demonstrated statistical superiority, achieving therapeutic success in 58.5% of patients compared to 43.6% in the nitrofurantoin group.

The most common adverse events (AEs) in patients treated with Blujepa were gastrointestinal, including diarrhea and nausea. Of all gastrointestinal AEs, 69% were mild, 28% were moderate, and 3% were severe. The safety and tolerability profile of Blujepa was consistent with previous clinical trials.

According to GSK, uUTIs affect up to 16 million women in the United States annually, making them the most common bacterial infection in women. Globally, over 50% of women will experience a uUTI during their lifetime, 30% of whom will also experience at least one recurrence.

The commercial launch of Blujepa in the United States is expected in the second half of this year. Development was partially funded by the US Department of Health and Human Services, Administration for Strategic Preparedness and Response, Biomedical Advanced Research and Development Authority, and the Defense Threat Reduction Agency.¹

According to Medscape, 25% to 40% of women between 20 and 40 years of age have had at least one UTI during their lifetime. Additionally, UTIs have resulted in over six million visits to physician offices within the past year, with 20% of cases reported in emergency departments. The incidence of UTIs in women tends to increase with age. However, women between 18 and 30 years of age are more likely to develop a UTI if they have also experienced honeymoon cystitis or pregnancy. In postmenopausal women, the rates tend to increase due to bladder or uterine prolapse, which causes incomplete bladder emptying.³

“For many, uUTIs can be a burden that severely impacts daily life,” said Thomas Hooton, MD, professor, clinical medicine, University of Miami School of Medicine, in the press release. “With an increasing number of patients experiencing recurrent infections, there remains a clear need for continued research of antimicrobials to help address ongoing patient challenges and the strain on healthcare systems.”

References

1. Blujepa (gepotidacin) approved by US FDA for treatment of uncomplicated urinary tract infections (uUTIs) in female adults and paediatric patients 12 years of age and older. GSK. March 25, 2025. Accessed March 26, 2025. https://www.gsk.com/en-gb/media/press-releases/blujepa-gepotidacin-approved-by-us-fda-for-treatment-of-uncomplicated-urinary-tract-infections/

2. Oral gepotidacin versus nitrofurantoin in patients with uncomplicated urinary tract infection (EAGLE-2 and EAGLE-3): two randomised, controlled, double-blind, double-dummy, phase 3, non-inferiority trials. ScienceDirect. Accessed March 26, 2025. https://www.sciencedirect.com/science/article/abs/pii/S0140673623021967#:~:text=EAGLE%2D2%20and%20EAGLE%2D3%20were%20phase%203%2C%20randomised%2C,patients%20were%20enrolled%20at%20219%20centres%20worldwide.&text=The%20trials%20are%20registered%20with%20ClinicalTrials.gov%20%2C,(EAGLE%2D2)%20and%20NCT04187144%20(EAGLE%2D3)%2C%20and%20are%20completed.

3. Urinary Tract Infection (UTI) and Cystitis (Bladder Infection) in Females. Medscape. Accessed March 26, 2025. https://emedicine.medscape.com/article/233101-overview#a5