Business

Blujepa (gepotidacin) Approved by US FDA for Treatment of Uncomplicated Urinary Tract Infections (uUTIs) in Female Adults and Pediatric Patients 12 Years of Age and Older

PHILADELPHIA, March 25, 2025--GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has approved 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.

articleGsk PlcMarch 25, 202510/company/glaxosmithkline-plc/news/blujepa-gepotidacin-approved-by-us-fda-for-treatment-of-uncomplicated-urinary-tract-infections-uutis-in-female-adults-and-pediatric-patients-12-years-of-age-and-older
Blujepa (gepotidacin) Approved by US FDA for Treatment of Uncomplicated Urinary Tract Infections (uUTIs) in Female Adults and Pediatric Patients 12 Years of Age and Older

About this update from Gsk Plc

[{"type":"image","alt":"","displaySize":"","headline":null,"caption":"","credit":null,"className":"","disableSlideshowImg":false,"size":{"original":{"width":480,"height":271,"url":"https://media.zenfs.com/en/business-wire.com/63fd92b0cb4d70f6f5435d31b7fcc404"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/UIzRNsR0jJOX0xB4c3ZHKQ--/YXBwaWQ9aGlnaGxhbmRlcjt3PTk2MDtoPTU0MjtjZj13ZWJw/https://media.zenfs.com/en/business-wire.com/63fd92b0cb4d70f6f5435d31b7fcc404","width":480,"height":271}},"lazy":false},{"type":"list","items":[{"val":[{"type":"text","content":"Blujepa is the first in a new class of oral antibiotics for uUTIs in nearly 30 years","length":84,"tagName":"p","attribs":{}}]},{"val":[{"type":"text","content":"Over half of all women experience a uUTI in their lifetime, with approximately 30% suffering from a recurrent episode","length":117,"tagName":"p","attribs":{}}]},{"val":[{"type":"text","content":"Approval based on data from the pivotal phase III EAGLE-2 and EAGLE-3 trials","length":76,"tagName":"p","attribs":{}}]}],"tagName":"ul","bulletedList":true,"length":277,"olType":false},{"type":"text","content":"PHILADELPHIA, March 25, 2025--(BUSINESS WIRE)--GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has approved 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.","length":486,"tagName":"p"},{"type":"text","content":"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.","length":159,"tagName":"p"},{"type":"text","content":"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."","length":402,"tagName":"p"},{"type":"text","content":"uUTIs are the most common infection in women, im...

More updates from Gsk Plc

US Food and Drug AdministrationStaphylococcus saprophyticuspediatric patientsurinary tract infectionsgepotidacinparticipantsnitrofurantoinoral antibioticstreatmentEscherichia coliinfectious diseasesSteph