GSK's Investigational Gonorrhea Vaccine Granted FDA Fast Track Designation

Intelligent Finance APP learned that GlaxoSmithKline PLC. (GSK.US) stated in a declaration that the U.S. Food and Drug Administration (FDA) has approved its Neisseria gonorrhoeae (NgG) investigational vaccine to enter the Fast Track. The Fast Track designation aims to facilitate the development and expedite the review of potentially significant new drugs and vaccines for the treatment or prevention of serious diseases with unmet medical needs.

The company pointed out that the candidate vaccine is currently in Phase II trials, aiming to demonstrate proof of concept by evaluating the efficacy of the NgG vaccine in healthy adults aged 18 to 50 who are considered at risk for gonorrhea. Gonorrhea is the second most prevalent bacterial sexually transmitted infection in the world, with an estimated 82 million new cases globally each year.