The European Commission (EC) has approved guselkumab (Tremfya) for the treatment of two types inflammatory bowel disease (IBD). 

Following two separate Marketing Authorisation announcements in April and May, guselkumab is now approved for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) and Crohn’s disease (CD), who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic treatment. Guselkumab is now the first dual-acting IL-23 inhibitor offering both intravenous (IV) and subcutaneous (SC) induction options.    

The CD approval is supported by results from the phase III 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 III 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 response and endoscopic remission 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 III studies demonstrated the efficacy of IV or SC guselkumab in achieving clinical and endoscopic endpoints. 

The UC approval is supported by data from the QUASAR programme, which consists of the phase IIb induction dose-ranging study and the phase III induction and maintenance studies, evaluating the efficacy and safety of guselkumab in adult patients with moderately to severely active UC who had an inadequate response, lost response or were intolerant to either conventional therapy or biologic treatment. 

Safety results across the QUASAR programme, both GALAXI studies and the GRAVITI study were consistent with previously approved indications for guselkumab, including psoriasis and psoriatic arthritis.

These EC approvals mark the third and fourth approved indications 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. 

In March 2025, Johnson & Johnson submitted an application to the European Medicines Agency, seeking approval for the SC induction regimen of guselkumab for the treatment of adults with moderately to severely active UC, based on results of the phase III ASTRO study.