The IDMC’s recommendation to stop the EAGLE-2 and 3 trials early for efficacy provides GSK with the opportunity to engage regulatory authorities as we work together to bring a new class of antibiotics to patients with uUTIs.” With the number of uUTIs caused by resistance bacteria increasing, new antibiotic treatments are necessary. There has been no new class of oral antibiotics for uUTI for over 20 years. This decision was based on a pre-specified interim analysis of efficacy and safety data in over 3000 patients across the trials.Ĭhris Corsico, SVP, Development, GSK, said: “Uncomplicated urinary tract infections (uUTI) are the most common outpatient infection with over half of all women developing a uUTI during their lifetime and more than a quarter of women suffering from recurrent uUTIs. GSK plc (LSE/NYSE: GSK) today announced that the pivotal phase III EAGLE-2 and EAGLE-3 trials evaluating gepotidacin, an investigational treatment for uncomplicated urinary tract infection (uUTI) in female adults and adolescents, will stop enrolment early for efficacy following a recommendation by the Independent Data Monitoring Committee (IDMC). GSK plans to submit a New Drug Application for gepotidacin to the US Food and Drug Administration (FDA) in H1 2023.Gepotidacin could be the first new novel oral antibiotic treatment for uncomplicated urinary tract infections in over 20 years.She is a medic robot who uses a protective drone to sustain teammates' health, while her poison rifle drains targets into submission. BLI-P is a Agent in Modern Combat Versus.
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