**GSK’s oral antibiotic Blujepa (gepotidacin) has been approved by the US Food and Drug Administration (FDA) to treat uncomplicated urinary tract infections (uUTIs).**
The drug, which is the first in a new class of oral antibiotics for uUTIs in nearly 30 years, has been specifically authorised to treat female adults and adolescents aged 12 years and older and weighing at least 40kg with uUTIs caused by E. coli, Klebsiella pneumoniae, Citrobacter freundii complex, Staphylococcus saprophyticus and Enterococcus faecalis.
More than half of women are affected by UTIs, common infections that affect the urinary tract, in their lifetime, and approximately 30% experience at least one recurrent episode.
Most uUTIs respond well to treatment. However, the number of uUTIs caused by drug-resistant bacteria is increasing, underscoring the need for new treatment options.
“For many, uUTIs can be a burden that severely impacts daily life,” said Thomas Hooton, professor of clinical medicine, University of Miami School of Medicine. “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 FDA’s decision on Blujepa was supported by positive results from the late-stage EAGLE-2 and EAGLE-3 trials, which evaluated the drug against standard-of-care nitrofurantoin in female adults and adolescents with a confirmed uUTI for five days.
In EAGLE-2, Blujepa demonstrated non-inferiority to nitrofurantoin, with therapeutic success occurring in 50.6% and 47% of patients, respectively.
Meanwhile, in EAGLE-3, Blujepa showed statistically significant superiority versus nitrofurantoin, with therapeutics success occurring in 58.5% of patients receiving GSK’s drug, compared to 43.6% of those being treated with standard-of-care.
The safety and tolerability profile of Blujepa in both trials was also shown to be consistent with previous trials of the drug.
GSK’s chief scientific officer, Tony Wood, described the approval as “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 uUTIs in nearly three decades, and to bring another option to patients given recurrent infections and rising rates of resistance to existing treatments,” he said.