Johnson & Johnson has announced a positive opinion from the CHMP recommending expanded marketing authorisation for TREMFYA (guselkumab) in ulcerative colitis. The decision supports a 400 mg subcutaneous induction regimen at weeks 0, 4 and 8 for adults with moderately to severely active disease.
The recommendation is based on phase 3 ASTRO study data showing statistically significant and clinically meaningful improvements across primary and secondary endpoints. Patients receiving guselkumab demonstrated better clinical, endoscopic and histologic-endoscopic outcomes compared with placebo.
Safety results were consistent with the known profile of guselkumab and aligned with findings from the GRAVITI study in Crohn’s disease. The subcutaneous option offers an alternative to intravenous administration, with studies indicating patient preference for SC delivery.
Mark Graham, Senior Director, Therapeutic Area Head, Immunology, J&J Innovative Medicine EMEA, said: “Today’s positive opinion marks a meaningful step forward in the treatment of UC, with guselkumab potentially becoming the first IL-23 inhibitor to offer a fully subcutaneous induction and maintenance regimen.”
He added: “This novel approach offers additional choice and simplicity for patients, caregivers and healthcare professionals, empowering them to choose a treatment regimen tailored to individual needs and lifestyles.”
Guselkumab is the first approved fully-human, dual-acting IL-23p19 subunit inhibitor that blocks IL-23 and binds to CD64. It is approved in the EU for moderate-to-severe psoriasis, active psoriatic arthritis, UC and Crohn’s disease.
The CHMP opinion follows EC approval of guselkumab for UC in April 2025 and its approval in CD in May 2025. If adopted, the new regimen will offer physicians greater flexibility in tailoring treatment for patients with inflammatory bowel disease.
