By Fineline Cube 
Johnson & Johnson (J&J, NYSE: JNJ) announced that the European Commission (EC) has approved Tremfya (guselkumab) for treating adults with moderately to severely active Crohn’s disease (CD). The approval includes patients who have had an inadequate response, lost response, or were intolerant to conventional therapy or biologic treatments. This decision covers both intravenous (IV) and subcutaneous (SC) induction regimens.
Clinical Trial Backing
The EC’s approval is supported by positive results from the Phase III GALAXI and GRAVITI trials. The pooled analysis of the GALAXI 2/3 studies showed that, at Week 48, guselkumab demonstrated superior efficacy compared to ustekinumab in terms of endoscopic response and remission rates. This makes Tremfya the first IL-23 inhibitor to achieve this milestone in a double-blind registrational study. The GRAVITI trial confirmed significant clinical and endoscopic efficacy after 12-week induction and 48-week maintenance, whether administered via IV or SC.
Guselkumab’s Regulatory Milestones
Guselkumab is the first fully human, dual-mechanism IL-23 inhibitor to receive approval. Its regulatory milestones in the EU include initial approval for moderate-to-severe plaque psoriasis in adults eligible for systemic therapy in November 2017, expanded approval for active psoriatic arthritis in adults with inadequate response to prior disease-modifying antirheumatic drugs (DMARDs) in November 2020, and approval for moderate-to-severe active ulcerative colitis (UC) in adults unresponsive to conventional or biologic therapies in April 2025.-Fineline Info & Tech