The FDA has approved GSK’s gepotidacin, the first antibiotic for uncomplicated urinary tract infections in 30 years.
The drug has been approved for female adults and adolescents with UTIs caused by common bacterial pathogens including E. coli and Klebsiella pneumoniae, according to a March 25 news release from the drugmaker.
The approval is based on two Phase 3 clinical trials which demonstrated that the drug was at least as effective as nitrofurantoin, a standard UTI treatment. The trials found that gepotidacin had a comparable safety profile, with mild to moderate gastrointestinal side effects being the most common.
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