Updated: Citing efficacy, GSK halts UTI antibiotic trial early, plans to file for FDA approval next year
GSK announced this morning that it is wrapping up two large clinical trials on a new antibiotic for uncomplicated urinary tract infections early, setting it up for an FDA filing next year.
An independent review group flagged that the non-inferiority trials testing GSK’s gepotidacin versus nitrofurantoin already met their primary endpoints in an interim analysis, according to GSK. The news comes as there are increasing concerns around drug-resistant UTIs and a lack of new antibiotic options for the common infection that some studies estimate impacts over half of all women in their lifetime.
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