The European Commission (EC) has granted marketing authorisation for Johnson & Johnson’s (J&J) Tremfya (guselkumab) to treat adults with moderately to severely active ulcerative colitis (UC) who have not responded adequately to conventional therapy or biologic treatment.
UC is a chronic inflammatory condition of the colon.
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Tremfya, developed by J&J, is the first fully-human, dual-acting interleukin-23 (IL-23) p19 subunit inhibitor that targets IL-23, a known driver of immune-mediated conditions, along with UC.
The approval is underpinned by the QUASAR programme data, which includes a Phase IIb induction dose-ranging trial and Phase III induction and maintenance trials.
These trials assessed guselkumab’s safety and efficacy in the target patient group.
45% of subjects on a 100mg subcutaneous dose every eight weeks and 50% on a 200mg dose every four weeks achieved clinical remission at week 44, higher than the 19% remission rate in placebo-treated subjects.
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By GlobalDataIn addition, 35% of patients on the 100mg dose and 34% on the 200mg dose attained endoscopic normalisation at week 44, versus 15% for placebo.
The safety profile of the therapy in UC aligns with its established safety record in psoriasis and psoriatic arthritis indications.
J&J innovative medicine EMEA [Europe, Middle East and Africa] immunology therapeutic area lead and senior director Mark Graham stated: “There is a significant need for new ulcerative colitis therapies that offer meaningful improvements in symptoms and the promise of remission – both overall clinical remission and visible healing of the colon through endoscopic normalisation.
“This approval builds on our sustained efforts to help improve the quality of life of patients, which can be significantly impacted from both a physical and mental health perspective.”
For UC treatment, guselkumab is initially given as a 200mg intravenous induction dose at weeks zero, four and eight.
The recommended maintenance dosage is 100mg administered subcutaneously at week 16, then every eight weeks.
If patients do not respond adequately to the induction treatment, a 200mg subcutaneous maintenance dose every four weeks may be considered.
This approval adds a third indication for the therapy in the EU. It was first approved there in November 2017 for moderate-to-severe plaque psoriasis and later for active psoriatic arthritis in November 2020.
The EC is also reviewing an expansion of guselkumab’s marketing authorisation to include treatment for moderately to severely active Crohn’s disease, with a decision expected later in 2025.
In early April 2025, the EC approved an extended indication for Janssen-Cilag International’s Darzalex (daratumumab) subcutaneous formulation for newly diagnosed multiple myeloma in adults.
