Johnson & Johnson announced that the FDA has approved 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 IIb/III 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: i. 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). ii. 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.”

For the treatment of UC, Tremfya is administered as a 200 mg induction dose intravenously at weeks zero, four and eight by a healthcare professional. The recommended maintenance dosage is 100 mg administered by SC injection at week 16, and every 8 weeks thereafter, or 200 mg administered by SC injection at week 12, and every 4 weeks thereafter. The SC maintenance dose can be self-administered by the patient or administered by a caregiver using Tremfya  after proper training. Use the lowest effective recommended dosage to maintain therapeutic response.

The QUASAR results reinforced the well-established safety profile of Tremfya including in the treatment of patients with UC. This FDA approval marks the third indication approved for Tremfya, which builds on Johnson & Johnson’s nearly 30-year legacy of immunology innovation. 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.