Wits Led Site Helps Deliver New Gonorrhoea Drug
- FHS Communications
Wits RHI is pleased that the U.S. Food and Drug Administration (FDA) has officially approved Nuzolvence® (zoliflodacin), a first-in-class oral antibiotic for the treatment of uncomplicated urogenital gonorrhoea. Co-developed by the Global Antibiotic Research and Development Partnership (GARDP) and Innoviva Speciality Therapeutics, the project was supported by the largest and most globally diverse Phase 3 gonorrhoea clinical trial to date, with findings recently published in The Lancet.
Wits Professor of Global Health and Infectious Diseases, Professor Sinead Delany?Moretlwe, led one of the participating global trial sites. “We are very proud to have played a role in this global clinical trial. Having a single?dose, oral treatment like this could be a game?changer for gonorrhoea control,” she said.
Zoliflodacin represents the first new treatment developed exclusively for gonorrhoea in decades. It has demonstrated effectiveness against all tested multidrug-resistant strains of Neisseria gonorrhoeae and shows no cross-resistance to existing therapies.
Professor Delany?Moretlwe explained that this approval has the potential to reduce the devastating impact of gonorrhoea on women in particular, as untreated infection can lead to infertility, life-threatening ectopic pregnancies, and chronic pelvic pain.
The consequences also extend to newborns. “Babies born to mothers with untreated gonorrhoea may be born prematurely and can develop serious eye infections that may lead to blindness,” she added.
She noted that the accessibility of zoliflodacin comes at a critical time. “With the number of gonorrhoea cases on the rise, there is great value in conducting trials that deliver effective new treatment options. This is essential to reduce the burden of disease and to prevent the global spread of highly drug-resistant gonorrhoea,” she said.
Read the full announcement: GARDP Website.