FDA Approves Blujepa for Uncomplicated Urinary Tract Infections

TUESDAY, March 25, 2025 (HealthDay News) — The U.S. Food and Drug Administration has approved Blujepa (gepotidacin) for the treatment of uncomplicated urinary tract infections (uUTIs) in adult women (weighing 40 kg or more) and children (12 years and older; weighing 40 kg or more).

Blujepa, a first-in-class oral antibiotic, is approved for treatment of uUTIs caused by Escherichia coli, Klebsiella pneumoniae, Citrobacter freundii complex, Staphylococcus saprophyticus, and Enterococcus faecalis.

The approval of Blujepa was based on results from the phase 3 EAGLE-2 and EAGLE-3 trials, which demonstrated the medication”s noninferiority and superiority, respectively, to nitrofurantoin (one of the leading current standard-of-care options for uUTI) in women and pediatric patients (aged 12 years and older) with a confirmed uUTI.

In EAGLE-2, therapeutic success occurred in 50.6 percent of patients taking Blujepa compared with 47.0 percent of those taking nitrofurantoin. In EAGLE-3, statistically significant superiority was demonstrated for Blujepa versus nitrofurantoin, with therapeutic success occurring in 58.5 versus 43.6 percent.

The most commonly reported adverse events in patients taking Blujepa were gastrointestinal, including diarrhea (16 percent) and nausea (9 percent). The maximum severity of these adverse events was mostly mild (69 percent) and moderate (28 percent). Severe gastrointestinal events occurred in less than 1 percent of all participants. Across both trials, there was one drug-related serious adverse event reported in each treatment arm (Blujepa and nitrofurantoin).

“The approval of Blujepa is a crucial milestone, with uUTIs among the most common infections in women,” Tony Wood, chief scientific officer of GSK, said in a statement. “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.”

The approval of Blujepa was granted to GlaxoSmithKline.

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