TREMFYA® (guselkumab) receives European Commission approval for subcutaneous induction through to maintenance in adults with ulcerative colitis, now the first IL-23 inhibitor with a fully subcutaneous dose regimen

Guselkumab offers the flexibility of self-administration from the start of treatment in both ulcerative colitis (UC) and Crohn’s disease (CD),1,2,3 providing the simplicity of a fully subcutaneous doseregimen in both diseases2,4

Guselkumab achieved significant rates of clinical remissiona and endoscopic healingb versus placebo at Week 12 with a subcutaneous induction dose regimen in UC,2,5 consistent with intravenous induction2,6

Beerse, Belgium (October 24, 2025) – Johnson & Johnson today announced that the European Commission (EC) has approved a subcutaneous (SC) induction dose regimen of TREMFYA® (guselkumab) for the treatment of adults with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic treatment.2 With this approval, guselkumab is the first IL-23 inhibitor7,8,9,10 to offer both SC and intravenous (IV) induction dose options for the treatment of UC and CD.2 The combined incidence of CD and UC is estimated to affect up to approximately 3 million people across Europe, and that number is increasing every year.11

Guselkumab is the first approved fully-human, dual-acting IL-23p19 subunit inhibitor that blocks IL-23 and binds to CD64,c a receptor on cells that produce IL-23.2,7,8,9,10 IL-23 is a cytokine secreted by activated monocyte/macrophages and dendritic cells that is known to be a driver of immune-mediated diseases including UC and CD.10,12 Findings for dual-acting are limited to in vitro studiesd and the clinical significance of this finding is not known.12,13

“Historically, IL-23 inhibitors have required initial IV infusions,7,8,9 which can create barriers when starting treatment and inconveniences for some patients and physicians,” said Laurent Peyrin-Biroulet, M.D., Ph.D., Head of the Inflammatory Bowel Disease (IBD) Unit at Nancy University Hospital in France and study investigator. “With today’s approval, UC patients and healthcare teams now have the option of self-administered subcutaneous injections for their induction period,1,2 offering similar established clinical and endoscopic outcomes, marking a significant advancement in managing this chronic inflammatory disease.”

The UC SC induction dose regimen approval is based on results from the Phase 3 ASTRO trial, which employed a treat-through design to evaluate the efficacy and safety of guselkumab SC induction therapy in adults with moderately to severely active UCe who had an inadequate response or intolerance to conventional therapy and advanced therapies.1,2,5 All multiplicity-controlled primary and secondary endpoints at Week 12 demonstrated statistically significant and clinically meaningful improvements with guselkumab 400 mg SC induction dose compared to placebo across all clinical and endoscopic measures.1,2

Significantly greater proportions of patients treated with guselkumab every four weeks (q4w) achieved clinical remission (28% vs. 6%; P