Johnson & Johnson’s TREMFYA (guselkumab) has gained approval from the European Commission (EC) for the treatment of adult patients suffering from moderately to severely active ulcerative colitis.
This regulatory approval applies to patients who have not adequately responded to or cannot tolerate conventional or biologic therapies. Ulcerative colitis is a chronic disease affecting the colon, where inflammation occurs in the lining.
Guselkumab is recognised as the first approved fully-human IL-23p19 subunit inhibitor that both blocks IL-23 and binds to CD64c, affecting cells that produce IL-23. This cytokine, secreted by activated monocytes/macrophages and dendritic cells, plays a role in immune-mediated conditions, such as ulcerative colitis.
J&J innovative medicine Europe, Middle East and Africa (EMEA) immunology therapeutic area lead and senior director Mark Graham said: “There is 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. We look forward to seeing guselkumab continue to raise the bar of efficacy and become the new standard of care in the treatment of UC.”
The European Commission’s decision is based on findings from the QUASAR programme. This includes a Phase 2b induction dose-ranging study and Phase 3 induction and maintenance studies.
The trials assessed the safety and efficacy of guselkumab in adults with a severe form of ulcerative colitis who have shown an inadequate response or intolerance to existing treatments.
In the QUASAR maintenance study, 45% of the patients administered 100mg of guselkumab subcutaneously every eight weeks and 50% of those given a 200mg dose every four weeks achieved clinical remission by Week 44. These outperformed the 19% remission rate observed in placebo-treated participants.
Additionally, endoscopic normalisation was observed in 35% of patients on the 100mg dose and 34% on the 200mg dose, compared to 15% in the placebo group.
The safety profile of guselkumab aligns with what is documented for its use in treating psoriasis and psoriatic arthritis, marking this as the third indication approved for the drug in the European Union (EU).
Johnson & Johnson initially secured European approval for guselkumab in November 2017 for moderate-to-severe plaque psoriasis and later in November 2020 for active psoriatic arthritis.
In parallel, the European Commission is evaluating a recommendation from the Committee for Medicinal Products for Human Use (CHMP) to expand guselkumab’s marketing authorisation. This is for the possibility of including the treatment for adult patients with moderately to severely active Crohn’s disease, with a decision expected later this year.
Separately, Johnson & Johnson shared preliminary results from Cohort 4 of the Phase 2b SunRISe-1 study, which is evaluating TAR-200, a gemcitabine-releasing system for bladder cancer patients.
The results indicate a disease-free survival rate exceeding 80% without reinduction and a bladder preservation rate of 94%. This system presents a potential alternative to surgery for patients with BCG-unresponsive, high-risk non-muscle-invasive bladder cancer, particularly those with papillary-only disease.
