India, Aug. 11 -- British drug major GSK plc (GSK,GSK.L) announced Monday that the US Food and Drug Administration has accepted for priority review a supplemental New Drug Application for gepotidacin as an oral option for the treatment of uncomplicated urogenital gonorrhoea in patients 12 years of age and older. The US regulator has assigned a Prescription Drug User Fee Act action date in December 2025.
The submission was supported by positive phase III data in patients with uncomplicated urogenital gonorrhoea in EAGLE 1 trial.
Gonorrhoea is a common, sexually transmitted infection caused by Neisseria gonorrhoeae, which has been recognised by the World Health Organization as a priority pathogen. The US Centers for Disease Control and Prev...