The US Food and Drug Administration (FDA) has approved GSK’s Blujepa (gepotidacin) for the treatment of female adults (≥40 kg) and pediatric patients (≥12 years, ≥40 kg) with uncomplicated urinary tract infections (uUTIs) caused by the following susceptible microorganisms: Escherichia coli, Klebsiella pneumoniae, Citrobacter freundii complex, Staphylococcus saprophyticus and Enterococcus faecalis.

Discovered by GSK scientists, Blujepa is a first-in-class oral antibiotic with a novel mechanism of action that is part of GSK’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 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 is based on positive results from the pivotal phase III EAGLE-2 and EAGLE-3 trials which demonstrated non-inferiority to nitrofurantoin, one of the leading current standard of care options for uUTI, in female adults (≥40 kg) and paediatric patients (≥12 years, ≥40 kg) with a confirmed uUTI. The safety and tolerability profile of Blujepa in the EAGLE-2 and EAGLE-3 phase III trials was consistent with previous trials.

The U.S. commercial launch is planned for the second half of 2025.

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