Shares in GSK PLC (LSE:GSK, NYSE:GSK) opened higher following the US Food and Drug Administration’s acceptance of gepotidacin for priority review as an oral treatment for uncomplicated urogenital gonorrhoea.
The decision, based on positive phase III data from the EAGLE-1 trial, sets a target FDA decision date of December 2025.
Gepotidacin offers a new oral alternative to current injectable therapies, addressing a significant unmet need for gonorrhoea, a common sexually transmitted infection recognised by the World Health Organisation as a priority pathogen.
In the trial, gepotidacin showed similar effectiveness to the standard treatment, with a 92.6% success rate and no serious drug-related adverse events.
With over 600,000 cases reported in the US in 2023, the new treatment could improve patient convenience and compliance.
Gepotidacin is also approved in the US for urinary tract infections, and regulatory reviews are underway in the UK and Australia.
Developed with support from US government agencies, the drug uses a novel mechanism to combat resistant bacteria.
GSK shares opened 1% higher at 1,411.45p.