GSK Wins US FDA Approval for Uncomplicated Urogenital Gonorrhoea Antibiotic

11:21 PM EST, 12/11/2025 (MT Newswires) -- The US Food and Drug Administration approved GSK's (GSK.L) supplemental new drug application for its uncomplicated urogenital gonorrhoea treatment, Blujepa, or gepotidacin. The antibiotic drug is indicated as an oral option to treat both adult and paediatric patients from the age of 12 years and weighing at least 45 kilograms, who do not have access to alternative treatment options, according to a Thursday release. The regulator's decision was backed by data from the Eagle-1 phase 3 trial, which showed that gepotidacin was a non-inferior treatment option compared with the standard of care combination treatment for gonorrhoea.