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European Commission approves TREMFYA (guselkumab), the first dual-acting IL-23 inhibitor offering both subcutaneous and intravenous induction options, for adult patients with moderately to severely active Crohn’s disease

May 7, 2025 – Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical – Crohn's disease, European Commission, Johnson & Johnson, Johnson & Johnson Innovative Medicine, clinical trials, marketing authorisation

TREMFYA (guselkumab) induction therapy administered either intravenously (GALAXI 2 and 3) or subcutaneously (GRAVITI) achieved the co-primary endpoints of clinical remissiona and endoscopic responseb at Week 12 compared to placebo
Guselkumab demonstrated statistically significant and clinically meaningful improvements in clinical remissiona and endoscopic responseb at Week 48 compared to placebo in all three studies
Data from the pooled GALAXI 2 and 3 studies showed that guselkumab demonstrated greater efficacy compared to ustekinumab in endoscopic responseb and endoscopic remissionc both at Week 48, including the biologic naïve and prior biologic failure subgroups
Guselkumab European Commission approval in Crohn’s disease builds upon recent ulcerative colitis approval, marking the fourth indication for this dual-acting IL-23 inhibitor in the European Union.

7 May 2025 — Beerse, Belgium — Johnson & Johnson today announced that the European Commission (EC) has approved a Marketing Authorisation (MA) for TREMFYA (guselkumab), the first dual-actingd IL-23 inhibitor offering both intravenous (IV) and subcutaneous (SC) induction options for the treatment of adults with moderately to severely active Crohn’s disease (CD) who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic treatment. This milestone builds upon the recent EC approval of guselkumab in moderately to severely active ulcerative colitis (UC). CD and UC are the two main forms of inflammatory bowel disease (IBD), which affects over four million people in Europe. Guselkumab is the first approved fully-human, dual-acting IL-23p19 subunit inhibitor that blocks IL-23 and binds to CD64, a receptor on cells that produce IL-23. 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 CD.

“Despite the progress made in the management of Crohn’s disease, many patients experience debilitating symptoms and are in need of new treatment options,” said Professor Silvio Danese, Director, Gastroenterology and Endoscopy, IRCCS Ospedale San Raffaele and University Vita-Salute San Raffaele, Milan, Italy. “The approval of guselkumab offers an IL-23 inhibitor that has shown robust rates of endoscopic remission with both subcutaneous and intravenous induction regimens and higher rates of endoscopic remission when compared to ustekinumab. Importantly, the fully subcutaneous regimen offers choice and flexibility for patients and healthcare professionals that has not been available before.”

This approval is supported by results from the Phase 3 GALAXI and GRAVITI programmes in moderately to severely active CD, in adults who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic treatment. Data from the pooled Phase 3 GALAXI 2 and 3 studies, which evaluated guselkumab IV induction and SC maintenance therapy, showed that guselkumab demonstrated greater efficacy compared to ustekinumab in endoscopic responseb and endoscopic remissionc at Week 48, the only IL-23 inhibitor to achieve this in a double-blinded registrational programme. The GRAVITI study evaluated guselkumab SC induction and maintenance therapy versus placebo following 12 weeks of induction and at 48 weeks of maintenance therapy. The results from these Phase 3 studies demonstrated the efficacy of IV or SC guselkumab in achieving clinical and endoscopic endpoints.

Safety results from both GALAXI studies and the GRAVITI study were consistent with the known safety profile of guselkumab in approved indications in psoriasis, psoriatic arthritis, and UC.

“Guselkumab is the first approved fully-human, dual-acting IL-23 inhibitor that offers a fully subcutaneous option for moderately to severely active Crohn’s disease. With the approval of guselkumab, it is now possible to achieve meaningful improvements in clinical and endoscopic outcomes,” said Mark Graham, Senior Director, Therapeutic Area Lead, Immunology, J&J Innovative Medicine EMEA. “Guselkumab provides people living with Crohn’s disease and healthcare professionals a new treatment option that is supported by data from multiple Phase 3 studies, showing greater efficacy versus ustekinumab across endoscopic response and endoscopic remission.”

For the treatment of CD, the recommended induction dose is 200 mg administered by IV infusion at Week 0, Week 4, and Week 8, or 400 mg administered by SC injection (given as two consecutive injections of 200 mg each) at Week 0, Week 4 and Week 8. After completion of the induction dose regimen, the recommended maintenance dose starting at Week 16 is 100 mg administered by subcutaneous injection every 8 weeks (q8w). Alternatively, for patients who do not show adequate therapeutic benefit to induction treatment according to clinical judgement, a maintenance dose regimen of 200 mg administered by subcutaneous injection starting at Week 12 and every 4 weeks (q4w) thereafter, may be considered.

This EC approval marks the fourth approved indication for guselkumab in the European Union (EU). Guselkumab first received approval in the EU in November 2017 for the treatment of moderate-to-severe psoriasis in adults who are candidates for systemic therapy. In November 2020, guselkumab received EU approval for active psoriatic arthritis in adult patients who have had an inadequate response or who have been intolerant to a prior disease-modifying antirheumatic drug therapy, followed by moderately to active UC, who had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic treatment, in April 2025. These approvals underscore Johnson & Johnson’s long-standing legacy in innovation and commitment to patients living with chronic immune-mediated diseases, including IBD. In March 2025, Johnson & Johnson submitted an application to the European Medicines Agency (EMA), seeking approval for the subcutaneous (SC) induction regimen of guselkumab for the treatment of adults with moderately to severely active UC, based on results of the Phase 3 ASTRO study.

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