LONDON (dpa-AFX) - 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 Prevention or CDC considers it as an urgent public health threat.
There is currently no vaccine licensed in the US for the prevention of gonorrhoea infection and the standard of care is injectable treatment which may not be suitable or available for all patients.
If approved, gepotidacin would offer a new oral option to US patients currently relying on injectable treatments.
This is the second major indication filed in the US for gepotidacin.
The FDA in March 2025 had approved gepotidacin 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 or uUTI.
The company noted that review of regulatory submissions for the uUTI indication is also ongoing in the UK and Australia.
According to GSK, the development of gepotidacin has been funded in part with federal funds from the US Department of Health and Human Services, Administration for Strategic Preparedness and Response, Biomedical Advanced Research and Development Authority (BARDA), and others.
For More Such Health News, visit rttnews.com
Copyright(c) 2025 RTTNews.com. All Rights Reserved
Copyright RTT News/dpa-AFX
© 2025 AFX News
