Tremfya® Approved by FDA for Ulcerative Colitis in Adults

Johnson & Johnson has announced that the U.S. Food and Drug Administration (FDA) has granted approval for TREMFYA® (guselkumab) to treat adults with moderately to severely active ulcerative colitis (UC). UC is a chronic condition impacting the large intestine, where the colon's lining becomes inflamed. TREMFYA® is unique as it is the first fully-human, dual-acting monoclonal antibody that not only blocks interleukin-23 (IL-23) but also binds to CD64, a receptor on cells that produce IL-23. IL-23 is a cytokine produced by monocytes, macrophages, and dendritic cells, which are known to drive immune-mediated diseases, including UC.

Dr. David T. Rubin, the lead investigator for the QUASAR program and Director of the Inflammatory Bowel Disease Center at the University of Chicago Medicine, emphasized the significance of the FDA's approval, noting that TREMFYA® has shown marked improvements in the symptoms of UC and normalization of the intestinal lining's endoscopic appearance. The approval is seen as a substantial advancement in treating this persistent inflammatory disease.

The approval is based on the results from the ongoing Phase 2b/3 QUASAR study, which assesses the efficacy and safety of TREMFYA® in adults with moderately to severely active UC who have not responded adequately to conventional therapy, other biologics, and JAK inhibitors. Key findings from the study include:

- 50% of patients receiving 200 mg TREMFYA® subcutaneously every four weeks and 45% of those receiving 100 mg every eight weeks reached clinical remission at week 44, compared to 19% of the placebo group.
- 34% of the 200 mg group and 35% of the 100 mg group achieved endoscopic remission at one year, in contrast to 15% in the placebo group.

Dr. Christopher Gasink, Vice President of Medical Affairs for Gastroenterology & Autoantibody at Johnson & Johnson, highlighted the need for new UC therapies that offer significant symptom relief and remission, noting TREMFYA®'s high rates of endoscopic remission after one year, which sets a new efficacy standard for UC treatment.

For treating UC, TREMFYA® is administered as an intravenous 200 mg induction dose at weeks zero, four, and eight by a healthcare professional. The maintenance dosage options include 100 mg via subcutaneous injection at week 16 and every eight weeks thereafter, or 200 mg every four weeks starting at week 12. Patients or caregivers can self-administer the subcutaneous maintenance dose following proper training. It is advised to use the lowest effective dosage to maintain therapeutic response.

The QUASAR results also confirmed the well-known safety profile of TREMFYA® for treating UC patients. This FDA approval extends TREMFYA®'s indications, adding to its existing approvals for moderate-to-severe plaque psoriasis and active psoriatic arthritis. TREMFYA® was first approved in the U.S. in July 2017 for plaque psoriasis and later in July 2020 for psoriatic arthritis. In June 2024, Johnson & Johnson filed a supplemental Biologics License Application to the FDA for TREMFYA® to treat moderately to severely active Crohn's disease.

Ulcerative colitis (UC) is an inflammatory bowel disease causing inflammation in the digestive tract, leading to damage to the colon lining. It results from an overactive immune response and presents a range of symptoms such as frequent bowel movements, rectal bleeding, persistent diarrhea, abdominal pain, weight loss, and fatigue. UC also has higher depression rates, affecting over a million people in the U.S., with prevalence on the rise.

TREMFYA® is the first dual-acting monoclonal antibody approved for UC, developed by Johnson & Johnson, and is available in the U.S., Europe, Canada, Japan, and other countries for treating plaque psoriasis and active psoriatic arthritis. Johnson & Johnson holds exclusive global marketing rights for TREMFYA®.