TREMFYA® (guselkumab) receives European Commission approval for adults with moderately to severely active ulcerative colitis, strengthening Johnson & Johnson's leadership in inflammatory bowel disease

Core Insights - The European Commission has approved guselkumab (TREMFYA®) for the treatment of moderately to severely active ulcerative colitis (UC), marking it as the first fully-human, dual-acting IL-23 inhibitor for this condition [1][2][4] - Guselkumab has shown statistically significant improvement in clinical remission and endoscopic normalization compared to placebo in clinical trials [3][6] Approval and Indications - Guselkumab is now approved for UC in addition to its existing indications for plaque psoriasis and psoriatic arthritis in the European Union [1][2] - The approval is based on data from the QUASAR program, which includes Phase 2b and Phase 3 studies evaluating its efficacy and safety in patients with inadequate response to conventional or biologic treatments [1][6] Clinical Efficacy - In the QUASAR maintenance study, 45% of patients receiving 100 mg of guselkumab every eight weeks achieved clinical remission at Week 44, compared to 19% in the placebo group [3] - Endoscopic normalization was achieved by 35% of patients on the 100 mg regimen and 34% on the 200 mg regimen, significantly higher than the 15% in the placebo group [3] Treatment Protocol - For UC, guselkumab is administered as a 200 mg induction dose intravenously at weeks 0, 4, and 8, followed by a maintenance dose of 100 mg subcutaneously every eight weeks [2][4] - An alternative maintenance regimen of 200 mg subcutaneously every four weeks may be considered for patients not showing adequate therapeutic benefit [2] Future Prospects - The European Commission is reviewing an expansion of the marketing authorization for guselkumab to include treatment for moderately to severely active Crohn's disease, with a decision expected later this year [4]