Overview
- The FDA cleared Blujepa (gepotidacin) for uncomplicated urogenital gonorrhea in patients 12 or older who weigh at least 45 kg, with use limited to cases lacking suitable alternatives.
- Approval rests on EAGLE-1 phase 3 results in The Lancet showing noninferiority to ceftriaxone plus azithromycin, with 92.6% urogenital cure for gepotidacin versus 91.2% for the comparator regimen.
- Gepotidacin is taken orally as two 3,000 mg doses and showed no serious drug-related adverse events in the trial, with mostly mild to moderate gastrointestinal side effects reported.
- The decision introduces an oral option alongside ceftriaxone, the current injection-based standard of care, as health agencies warn of rising resistance in Neisseria gonorrhoeae.
- A separate first-in-class oral candidate, zoliflodacin, cured over 90% of urogenital infections in a phase 3 study and is awaiting an FDA decision expected on Dec. 15.