GSK receives FDA Fast Track designation for investigational gonorrhea vaccine

GSK plc announced the U.S. Food and Drug Administration has granted a Fast Track designation for its Neisseria gonorrhoeae investigational vaccine. The vaccine candidate is currently in an ongoing Phase II trial and aims to demonstrate proof of concept by assessing the efficacy of the NgG vaccine in healthy adults, 18 to 50 years of age, considered at risk of gonorrhea. Fast Track designation is intended to facilitate the development and expedite the review of potentially important new drugs and vaccines to treat or prevent serious conditions with unmet medical needs. Phil Dormitzer, Global Head of Vaccines R&D, GSK, said: “We welcome the FDA’s decision to grant Fast Track designation for our new vaccine candidate against Neisseria gonorrhoeae infection. With a high and growing incidence, gonorrhea is a major concern for sexual and reproductive health around the globe. This designation recognizes 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 Organization.”