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GSK’s Blujepa Approved by FDA for Treatment of uUTIs

Blujepa’s approval is based on positive results from the pivotal phase III EAGLE-2 and EAGLE-3 trials.

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By: Charlie Sternberg

Associate Editor

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...

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