Johnson & Johnson has announced that the U.S. Food and Drug Administration (FDA) has granted approval for Tremfya (guselkumab) as a treatment for adults with moderately to severely active Crohn’s disease (CD). This approval marks a significant milestone, as Tremfya is the first and only IL-23 inhibitor to offer both subcutaneous (SC) and intravenous (IV) induction treatment options for patients.

The decision builds on Tremfya’s previous FDA approval for the treatment of moderately to severely active ulcerative colitis (UC), one of the two main forms of inflammatory bowel disease (IBD) that collectively affect nearly three million Americans.

Tremfya stands out as the first fully human, dual-acting monoclonal antibody approved for use in CD. It works by blocking IL-23, a key cytokine involved in driving immune-mediated diseases, while also binding to CD64, a receptor found on immune cells that produce IL-23. This dual mechanism aims to provide more targeted and effective treatment for patients struggling with chronic gastrointestinal inflammation.

“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. Dr. Panaccione, who served as the lead investigator for the Phase 3 GRAVITI study, emphasized that the approval of Tremfya represents an important advancement. “The approval of Tremfya offers an IL-23 inhibitor that has shown robust rates of endoscopic remission with both subcutaneous and intravenous induction regimens. Importantly, the fully subcutaneous regimen offers choice and flexibility for patients and providers that have not been available before.”

The availability of both SC and IV induction options allows healthcare providers to tailor treatment based on individual patient needs, enhancing convenience and improving access to advanced care in Crohn’s disease management.