The U.S. Food and Drug Administration (FDA) has approved TREMFYA (guselkumab) for the treatment of adults with moderately to severely active Crohn’s disease (CD), confirming its status as the first and only interleukin (IL)-23 inhibitor to offer both subcutaneous (SC) and intravenous (IV) induction options. Johnson & Johnson, the pharmaceutical company behind the drug, made the announcement on March 20, 2025, further extending the utility of this medication after its previous approval for ulcerative colitis in 2024.
Crohn’s disease, which affects an estimated three million Americans, is one of the two main forms of inflammatory bowel disease (IBD). By inhibiting IL-23, a cytokine responsible for immune-mediated diseases like CD, TREMFYA aims to alleviate debilitating symptoms and improve the quality of life for many patients.
“Despite the progress in the management of Crohn’s disease, many patients experience debilitating symptoms and are in need of new treatment options,” said Dr. Remo Panaccione, Professor of Medicine and Director of the Inflammatory Bowel Disease Unit at the University of Calgary and lead investigator of the Phase 3 GRAVITI study. “The approval of TREMFYA offers an IL-23 inhibitor that has shown robust rates of endoscopic remission with both subcutaneous and intravenous induction regimens.”
The FDA's decision was underpinned by data from multiple Phase 3 clinical trials that assessed the efficacy of TREMFYA in over 1,300 patients who were inadequately treated or intolerant to existing therapies. Notably, the GRAVITI study highlighted that at Week 12, 56% of patients receiving 400 mg of TREMFYA via SC administration achieved clinical remission, compared to only 22% in the placebo group (p<0.001). Meanwhile, within the same timeframe, a striking 34% of patients on the same treatment secured endoscopic response versus 15% on placebo.</p>
When evaluated against STELARA (ustekinumab), the data revealed that TREMFYA was superior across all pooled endoscopic endpoints, establishing itself as the only IL-23 inhibitor to achieve this in a double-blinded clinical program. The findings from the GALAXI studies, which were part of the regulatory submission, demonstrated that TREMFYA achieved notable success levels relative to STELARA. For instance, in the GALAXI 2 study, 47% of patients treated with TREMFYA 200 mg IV achieved clinical remission versus 20% on placebo (p<0.001). Additionally, 36% displayed endoscopic response compared to just 9% in the placebo group.</p>
“With the approval of TREMFYA, it is now possible to achieve meaningful improvements in clinical and endoscopic outcomes with the flexibility of self-administration from the start,” remarked Dr. Chris Gasink, Vice President of Medical Affairs, Gastroenterology & Autoantibody for Johnson & Johnson Innovative Medicine. This flexibility is particularly important for patients seeking controlled treatment options.
The approval for TREMFYA follows its existing indications for moderately to severely active ulcerative colitis, moderate-to-severe plaque psoriasis, and active psoriatic arthritis. Johnson & Johnson’s trajectory with guselkumab underscores its commitment to addressing chronic immune-mediated diseases with innovative treatments. The therapeutic potential of TREMFYA represents a significant advance in the care for those afflicted by IBD.
Following the treatment protocol outlined, the recommended SC induction dosage is set at 400 mg administered as two consecutive injections of 200 mg each, spaced at Weeks 0, 4, and 8. The maintenance dosing allows for either 100 mg at Week 16 followed by 8-week intervals or a higher dosage of 200 mg every 4 weeks, thereby tailoring the treatment to individual patient needs and responses.
Johnson & Johnson also offers a patient support program named TREMFYA® withMe, aiming to ensure swift access to the treatment for commercially insured patients, with potential for initial doses to be available in as little as 24 hours post-prescription.
As Crohn’s disease continues to challenge the lives of millions, the approval of TREMFYA provides renewed hope for effective management. The responsibilities lie in ensuring that patients and healthcare providers are well-informed about treatment options, facilitating better health outcomes.
The future implications surrounding the management of Crohn’s disease may shift with this approval, offering a needed avenue for those struggling with chronic symptoms while reinforcing the importance of ongoing research and innovation in the field.
Johnson & Johnson remains committed to supporting ongoing research and providing comprehensive care solutions for patients dealing with Crohn’s disease and other inflammatory conditions, as demonstrated by their sustained investment in therapies like TREMFYA.
In summary, the approval of TREMFYA for Crohn’s disease adds to a growing portfolio of treatment options that could help patients effectively manage their condition, paving the way for better health outcomes in the long term.
