GSK plc reported that Blujepa (gepotidacin) has been approved by the US Food and Drug Administration (FDA) to treat uncomplicated urinary tract infections in female adults (weighing 40 kg or more) and pediatric patients (aged 12 years or older, weighing 40 kg or more) caused by susceptible microorganisms such as Escherichia coli, Klebsiella pneumoniae, Citrobacter freundii complex, Staphylococcus saprophyticus, and Enterococcus faecalis.
Blujepa, which was discovered by GSK scientists, is a first-in-class oral antibiotic with a novel mechanism of action that is part of the company’s infectious diseases portfolio.
Tony Wood, Chief Scientific Officer, GSK, said: “The approval of Blujepa is a crucial milestone with uUTIs among the most common infections in women. We are proud to have developed Blujepa, the first in a new class of oral antibiotics for UTIs in nearly three decades, and to bring another option to patients given recurrent infections and rising rates of resistance to existing treatments.”
Up to 16 million women in the US are affected with UTIs each year, making them the most prevalent illness in women. More than half of women get UTI at some point in their lives, and over 30% experience at least one recurring episode. This can result in substantial patient burden, including discomfort and limitations on everyday activities. Since drug-resistant bacteria are increasingly causing UTIs and increasing treatment failure rates, new therapies are required.
Thomas Hooton, MD, Professor of Clinical Medicine, University of Miami School of Medicine said: “For many, UTIs can be a burden that severely impacts daily life. 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.”
The approval was based on the pivotal phase III EAGLE-2 and EAGLE-3 trials, which showed non-inferiority to nitrofurantoin, one of the top current standard of care options for UTI, in female Adults (weighing 40 kg or more) and pediatric Patients (aged 12 years or older, weighing 40 kg or more) with a Confirmed Urinary Tract Infection (UTI). These findings served as the basis for the approval. In EAGLE-2, 50.6% (162/320) of participants experienced non-inferiority in therapeutic success with Blujepa, while 47.0% (135/287) experienced nitrofurantoin (covariate-adjusted treatment difference 4.3%, 95% CI (-3.6, 12.1)). Blujepa outperformed nitrofurantoin in EAGLE-3 in a statistically significant way (one-sided p-value 0.0003). In contrast to 43.6% (115/264) for nitrofurantoin (covariate-adjusted treatment difference 14.6%, 95% CI (6.4, 22.8)), 58.5% (162/277) of subjects experienced therapeutic success.
In the EAGLE-2 and EAGLE-3 phase III trials, Blujepa’s safety and tolerability profile matched those of earlier studies. Among Blujepa participants, gastrointestinal (GI) adverse events were the most frequently reported AEs. The most frequent symptom was diarrhea, which affected 16% of individuals, followed by nausea (9%). The most prevalent maximum severity among those who reported GI adverse events in the Blujepa group was mild (69% Grade 1), followed by moderate (28% Grade 2). Grade 3 GI events occurred in less than 1% of all participants and accounted for 3% of all GI events in patients. During the two studies, there was one significant adverse event associated with each of the two treatment arms (nitrofurantoin and Blujepa).
The company will launch this commercially in the US in the second half of 2025. Blujepa (gepotidacin) was developed in part using federal funds from the Defense Threat Reduction Agency under agreement number HDTRA1-07-9-0002 and the US Department of Health and Human Services, Administration for Strategic Preparedness and Response, Biomedical Advanced Research and Development Authority (BARDA), under Other Transaction Agreement number HHSO100201300011C.
