The U.S. Food and Drug Administration (FDA) has approved Johnson & Johnson’s TREMFYA (guselkumab) for the treatment of adults with moderately to severely active ulcerative colitis (UC), a chronic disease of the large intestine in which the lining of the colon becomes inflamed.
TREMFYA is the first and only approved fully-human, dual-acting monoclonal antibody that blocks IL-23 while also binding 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 UC.
“Treatment with TREMFYA resulted in significant improvement in the chronic symptoms of ulcerative colitis, and importantly, normalization in the endoscopic appearance of the intestinal lining,” said David T. Rubin, MD, Director, Inflammatory Bowel Disease Center, University of Chicago Medicine, and lead investigator for the QUASAR program. “Today’s approval of TREMFYA builds on the clinical and well-established safety profile of this IL-23 inhibitor and marks a significant step forward in the treatment of this chronic inflammatory disease.”
The UC approval is supported by data from the pivotal, ongoing Phase 2b/3 QUASAR study evaluating the efficacy and safety of TREMFYA in adult patients with moderately to severely active UC who experienced an inadequate response or who demonstrate intolerance to conventional therapy, other biologics and/or JAK inhibitors. Highlights from QUASAR showed:
- 50% of patients receiving TREMFYA 200 mg subcutaneous (SC) maintenance every four weeks (q4w) and 45% of patients receiving TREMFYA 100 mg SC every eight weeks (q8w) achieved primary endpoint of clinical remission at week 44 compared to 19% placebo-treated patients (p<0.001).
- 34% (200 mg) and 35% (100 mg) of patients achieved endoscopic remission at one year with TREMFYA SC maintenance therapy compared to 15% placebo-treated patients (p<0.001).
“There is a significant need for new UC therapies that offer meaningful improvements in symptoms and the promise of remission, both overall clinical remission as well as delivering visible healing of the colon through endoscopic remission,” said Christopher Gasink, MD, Vice President, Medical Affairs, Gastroenterology & Autoantibody, Johnson & Johnson Innovative Medicine. “In the QUASAR clinical program, TREMFYA demonstrated high reported rates of endoscopic remission at one year of treatment, continuing to raise the bar for efficacy in the treatment of this inflammatory bowel disease.”
This FDA approval marks the third indication approved for TREMFYA. TREMFYA first received approval in the U.S. in July 2017 for the treatment of adult patients with moderate-to-severe plaque psoriasis and received subsequent approval for adults with active psoriatic arthritis in July 2020. In June 2024, Johnson & Johnson submitted a supplemental Biologics License Application (sBLA) to the FDA seeking approval of TREMFYA for the treatment of adult patients with moderately to severely active Crohn’s disease.
