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GSK plc GSK announced that the FDA has approved its oral antibiotic gepotidacin for treating uncomplicated urinary tract infections (uUTIs) in female adults and adolescents. A commercial launch for the drug is planned in second-half 2025 under the brand name Blujepa.
This approval for Blujepa marks the introduction of a new class of oral antibiotics for uUTIs in nearly 30 years. Per GSK, the drug targets a different part of the bacteria than most existing antibiotics, making it effective against resistant strains. Additionally, the risk of bacterial resistance is low, as mutations would need to occur in both enzymes that Blujepa targets.
The drug has been designed to treat uUTIs caused by susceptible microorganisms like Escherichia coli, Klebsiella pneumoniae, Citrobacter freundii complex, Staphylococcus saprophyticus and Enterococcus faecalis.
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More on GSK’s Blujepa
The FDA approval is supported by data from two late-stage studies, EAGLE-2 and EAGLE-3, which showed that Blujepa is at least as effective as nitrofurantoin, a leading standard-of-care (SOC) therapy for uUTIs. In EAGLE-2, the drug met its primary goal of non-inferiority, with a therapeutic success rate of 50.6% versus 47.0% for nitrofurantoin. Data from the EAGLE-3 study showed Blujepa’s superiority, with a success rate of 58.5% compared to 43.6% for nitrofurantoin.
Besides uUTI, GSK is also evaluating the safety and efficacy of Blujepa to ceftriaxone plus azithromycin in patients with uncomplicated urogenital gonorrhoea caused by Neisseria gonorrhoeae.
The drug is one of five new products/line extensions GSK expects this year, potentially boosting its bottom line amid declining vaccine sales. Other planned launches include Blenrep (for multiple myeloma), depemokimab (chronic rhinosinusitis with nasal polyps and asthma with type II inflammation), Nucala (for chronic obstructive pulmonary disease) and the pentavalent MenABCWY meningococcal vaccine.
Blujepa has been developed internally by GSK scientists, with part-funding from the U.S. government.
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