Johnson & Johnson Receives FDA Approval for Tremfya in Ulcerative Colitis

Johnson & Johnson today announced that the FDA has approved Tremfya (guselkumab) for the treatment of adults with moderately to severely active ulcerative colitis (UC). Tremfya is an IL-23 inhibitor that selectively blocks the p19 subunit of IL-23. In the Phase 3 QUASAR induction and maintenance trials, Tremfya demonstrated statistically significant improvements in clinical remission, endoscopic improvement, and histologic-endoscopic mucosal improvement compared to placebo. This approval expands Tremfya's indications beyond plaque psoriasis and psoriatic arthritis into inflammatory bowel disease. J&J continues to study Tremfya in Crohn's disease.