Gepotidacin Approved for Uncomplicated UTI

With its novel mechanism of action, gepotidacin is the first oral antibiotic approved for UTI in over 20 years.

Gepotidacin (Blujepa) is a first-in-class antibiotic that blocks bacterial DNA replication by inhibiting two type II topoisomerase enzymes. It was recently FDA-approved for treatment of female adult and pediatric patients 12 years of age and older who have uncomplicated urinary tract infections caused by susceptible Escherichia coli, Klebsiella pneumoniae, Citrobacter freundii complex, Staphylococcus saprophyticus, and Enterococcus faecalis.

The studies that led to FDA approval

In two phase 3 noninferiority trials (EAGLE-2 and EAGLE-3), oral gepotidacin was compared to nitrofurantoin for treatment of uncomplicated urinary tract infections (UTIs) in nonpregnant girls and women aged >12 years. Eligible patients had at least two symptoms of dy…

Author

George Sakoulas, MD

Disclosures

Consultant/Advisory BoardParatek Pharmaceuticals; Nestle Corp.; AbbVie; Shionogi

Speaker’s BureauAllergan/AbbVie; Paratek Pharmaceuticals; Nestle Corp.

RoyaltiesUpToDate

Editorial BoardsAntimicrobial Agents and Chemotherapy; Open Forum Infectious Diseases