11th Aug 2025 08:40
(Alliance News) - GSK PLC on Monday said its gepotidacin drug has been accepted for priority review in the US as an oral option for the treatment of a form of sexually transmitted infection gonorrhoea.
The London-based pharmaceuticals company said the submission was supported by "positive" by Eagle-1 phase three trial data.
This showed gepotidacin was "non-inferior" when compared to intramuscular ceftriaxone plus oral azithromycin combined therapy, a leading combination treatment regimen for gonorrhoea.
The safety and tolerability profile of gepotidacin in the trial was consistent with results seen in previous clinical trials, with no serious drug related adverse events observed.
"If approved, gepotidacin would offer a new oral option to US patients currently relying on injectable treatments," GSK said.
The US Food & Drug Administration said the drug has been accepted for priority review to treat uncomplicated urogenital gonorrhoea in patients aged 12 and older.
The FDA has assigned a Prescription Drug User Fee Act action date in December.
Back in March, gepotidacin was approved by the FDA under the licensing name Blujepa as oral treatment for female adult and paediatric patients 12 years of age and older with uncomplicated urinary tract infection.
Review of regulatory submissions for the uUTI indication also are taking place in the UK and Australia.
Shares in GSK were up 1.1% at 1,410.50 pence each in London on Monday morning. The wider FTSE 100 index was up 0.4%
By Jeremy Cutler, Alliance News reporter
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