FDA Approves Guselkumab (Tremfya) for Ulcerative Colitis

The US Food and Drug Administration has approved Johnson & Johnson’s guselkumab (Tremfya) for the treatment of adults with moderately to severely active ulcerative colitis (UC).

Announced on September 11, 2024, the decision is based on data from the ongoing phase 2b/3 QUASAR study demonstrating guselkumab’s ability to induce clinical and endoscopic remission 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. The approval makes guselkumab the first and only approved fully-human, dual-acting monoclonal antibody that blocks interleukin (IL)-23 while also binding to CD64, a receptor on cells that produce IL-23.

“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 Rubin, MD, director of the Inflammatory Bowel Disease Center at 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.”

In QUASAR, 50% of patients receiving guselkumab 200 mg subcutaneous (SC) maintenance every four weeks (q4w) and 45% of patients receiving guselkumab 100 mg SC every eight weeks (q8w) achieved the primary endpoint of clinical remission at week 44 compared to 19% placebo-treated patients (P <.001). Additionally, 34% (200 mg) and 35% (100 mg) of patients achieved endoscopic remission at 1 year with guselkumab SC maintenance therapy compared to 15% of placebo-treated patients (P <.001).

According to the release from Johnson & Johnson, for the treatment of UC, guselkumab is administered as a 200 mg induction dose intravenously at weeks zero, 4, and 8 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. Of note, the SC maintenance dose can be self-administered by the patient or administered by a caregiver using guselkumab.

“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 of Medical Affairs for Gastroenterology and Autoantibody at 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.”

References

1. ^{Johnson and Johnson. TREMFYA® (guselkumab) receives U.S. FDA approval for adults with moderately to severely active ulcerative colitis, strengthening Johnson & Johnson’s leadership in inflammatory bowel disease. September 11, 2024. Accessed September 11, 2024. https://www.jnj.com/media-center/press-releases/tremfya-guselkumab-receives-u-s-fda-approval-for-adults-with-moderately-to-severely-active-ulcerative-colitis-strengthening-johnson-johnsons-leadership-in-inflammatory-bowel-disease}
2. ^{Iapoce, C. Guselkumab Achieves Clinical, Endoscopic Remission in Ulcerative Colitis. HCPLive. May 20, 2024. Accessed September 11, 2024. https://www.hcplive.com/view/guselkumab-achieves-clinical-endoscopic-remission-ulcerative-colitis}