Guselkumab, the first IL-23 inhibitor, has been approved by the FDA for treating adults with moderately to severely active Crohn's disease based on GRAVITI and GALAXI studies. In the GRAVITI study, guselkumab demonstrated significant clinical remission and endoscopic response compared to placebo. Similar positive outcomes were observed in the GALAXI 2 and 3 studies, leading to the approval of guselkumab for its efficacy in inducing and maintaining clinical and endoscopic remission in Crohn’s disease patients.

Source: Johnson & Johnson