The US Food and Drug Administration (FDA) approved GSK plc’s GSK Blujepa (gepotidacin) for the treatment of female adults (≥40 kg) and pediatric patients (≥12 years, ≥40 kg) with uncomplicated urinary tract infections (uUTIs).
In a press release on Tuesday, the company said the U.S. commercial launch is planned in 2H 2025.
UTIs are the most common infection in women, impacting up to 16 million women in the US annually.
The approval is based on results from the pivotal phase 3 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 and pediatric patients with a confirmed uUTI.
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In EAGLE-2, Blujepa demonstrated non-inferiority in therapeutic success, which occurred in 50.6% (162/320) of participants, compared to 47.0% (135/287) for nitrofurantoin.
In EAGLE-3, Blujepa demonstrated statistically significant superiority versus nitrofurantoin.
Therapeutic success occurred in 58.5% (162/277) of participants compared to 43.6% (115/264) for nitrofurantoin.
The development of Blujepa has been partially funded by federal funds from the US Department of Health and Human Services, the Administration for Strategic Preparedness and Response, the Biomedical Advanced Research and Development Authority, and federal funds awarded by the Defense Threat Reduction Agency.
Price Action: GSK stock is down 1.63% at $37.95 at the last check Wednesday.
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