葛兰素史克治疗尿路感染的抗生素接受FDA优先审查

2024-10-16 19:01

GSK (NYSE:GSK) announced Wednesday that the U.S. FDA accepted its new drug application for the bactericidal antibiotic gepotidacin for priority review as a treatment for females with uncomplicated urinary tract infections (uUTIs).
With the NDA, the British drugmaker expects FDA approval to market gepotidacin for female adults and adolescents with uncomplicated urinary tract infections.
The NDA is backed by data from the company's EAGLE-2 and EAGLE-3 trials. Both studies demonstrated that gepotidacin performed at least at a similar level (non-inferiority) to nitrofurantoin, the current standard of care for uUTI.
EAGLE-3, in particular, indicated statistically significant superiority for gepotidacin versus nitrofurantoin. In both trials, the study drug's safety and tolerability profile was found to be consistent with prior findings.
The FDA has assigned March 26, 2025, as the Prescription Drug User Fee Act (PDUFA) action date in relation to the NDA.

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