FDA Approves Blujepa: First New Oral Antibiotic for Uncomplicated UTIs in Nearly 30 Years

The FDA has approved GSK's Blujepa (gepotidacin) for treating uncomplicated urinary tract infections (uUTIs) in female adults and pediatric patients 12 years and older14.

Blujepa is the first new class of oral antibiotics for uUTIs approved in nearly 30 years45.

The drug is effective against common uropathogens, including drug-resistant strains of Escherichia coli, Klebsiella pneumoniae, Citrobacter freundii complex, Staphylococcus saprophyticus, and Enterococcus faecalis46.

Approval was based on positive results from the phase III EAGLE-2 and EAGLE-3 trials, which demonstrated non-inferiority to nitrofurantoin, a current standard-of-care treatment45.

Over 50% of women experience a uUTI in their lifetime, with approximately 30% suffering from recurrent infections16.

Blujepa is a first-in-class triazaacenaphthylene antibiotic that inhibits bacterial DNA replication through a novel mechanism of action6.

The most common adverse event reported was diarrhea, occurring in 16-18% of patients in the clinical trials5.

GSK plans to launch Blujepa in the US market in the second half of 202546.

The development of Blujepa was partially funded by the US Department of Health and Human Services and the Defense Threat Reduction Agency6.

This approval addresses the growing need for new treatments due to increasing antibiotic resistance in uUTIs15.

Sources:

1. https://www.contagionlive.com/view/fda-approves-gepotidacin-blujepa-for-uncomplicated-urinary-tract-infections

4. https://www.morningstar.com/news/dow-jones/202503257759/gsks-treatment-for-uncomplicated-urinary-tract-infections-approved-in-us

5. https://www.ajmc.com/view/fda-approves-first-new-class-of-oral-antibiotics-for-uncomplicated-utis-in-nearly-30-years

6. https://www.gsk.com/media/11932/blujepa-global-fda-approval.pdf