The U.S. FDA has approved GSK’s gepotidacin, branded Blujepa, for the treatment of uncomplicated urinary tract infections (uUTIs), marking the first in a new class of oral antibiotics for uUTIs in nearly 30 years.
Blujepa, an oral triazaacenaphthylene antibiotic that inhibits bacterial DNA replication, is approved for the treatment of female adults and pediatric patients (≥12 years) with uUTIs caused by the following susceptible microorganisms: Escherichia coli, Klebsiella pneumoniae, Citrobacter freundii complex, Staphylococcus saprophyticus and Enterococcus faecalis. The drug is the result of a 2013 public-private partnership between GSK and the Biomedical Advanced Research and Development Authority (BARDA).
The approval is based on positive results from the pivotal phase 3 EAGLE-2 and EAGLE-3 trials which demonstrated non-inferiority to nitrofurantoin, one of the leading current standard of care options for uUTIs. New treatments are needed as the number of infections caused by drug-resistant bacteria are increasing, driving up treatment failure rates.
Last year, GSK shared positive phase 3 data for the antibiotic in gonorrhea as well, teeing up another possible FDA submission. In the 600-patient gonorrhea trial, gepotidacin demonstrated non-inferiority, with a 92.6% success rate compared to a 91.2% success rate for intramuscular ceftriaxone plus oral azithromycin.
According to GSK, the U.S. commercial launch for Blujepa in uUTIs is planned for the second half of 2025.