British drugmaker GSK announced today that it has received Fast Track designation from the US Food and Drug Administration (FDA) for its investigational gonorrhea vaccine.
The designation means that the NgG vaccine, which is in an ongoing phase 2 trial, will receive expedited review by FDA officials. The phase 2 trial began in November 2022 and will include 750 participants in eight countries, with the aim of assessing the efficacy of the vaccine in healthy adults ages 18 to 50 who are considered at risk of Neisseria gonorrhoeae infection.
The FDA's Fast Track program aims to hasten the development and review of new drugs and vaccines for serious conditions with unmet medical needs. In addition to being the second most common sexually transmitted infection worldwide, gonorrhea is now resistant to most antibiotics and is considered an urgent unmet medical need by global health officials.
Gonorrhoea is a major concern for sexual and reproductive health around the globe.
"With a high and growing incidence, gonorrhoea is a major concern for sexual and reproductive health around the globe," Phil Dormitzer, MD, PhD, GSK's head of global vaccines R&D, said in a company press release. "This designation recognises the potential for a vaccine that could help protect millions of people across the world against the serious health consequences of infection with a bacterium that is considered a 'high priority' pathogen by the World Health Organisation."