UK-based pharmaceutical company GlaxoSmithKline (GSK; NYSE: GSK) announced that it has received marketing approval from the US Food and Drug Administration (FDA) for its drug Blujepa (gepotidacin). The approval allows the use of Blujepa in female adults (≥40 kg) and pediatric patients (≥12 years, ≥40 kg) with uncomplicated urinary tract infections (uUTIs) caused by specific susceptible microorganisms.
Drug Mechanism and Innovation
Blujepa is a first-in-class triazaacenaphthylene antibiotic that works by inhibiting bacterial DNA replication through a unique binding site and a novel mechanism of action. It provides well-balanced inhibition of two different Type II topoisomerase enzymes, offering activity against most target uropathogens, including Escherichia coli and Staphylococcus saprophyticus, as well as Neisseria gonorrhoeae, including strains resistant to current antibiotics. The distinct mechanism of action results in a lower potential for resistance development.
Clinical Trial Support
The FDA approval is supported by positive results from the pivotal Phase III EAGLE-2 and EAGLE-3 studies. These trials demonstrated that Blujepa is non-inferior to nitrofurantoin in treating uUTIs in female adults (≥40 kg) and pediatric patients (≥12 years, ≥40 kg) with confirmed infections.-Fineline Info & Tech
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