FDA Approves Tremfya for Ulcerative Colitis

The FDA has approved Johnson & Johnson’s supplemental application for Tremfya (guselkumab) to treat adults with moderately to severely active ulcerative colitis (UC).

Tremfya is 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 that is a driver of immune-mediated diseases including ulcerative colitis, a chronic disease of the large intestine.

David T. Rubin, M.D.

“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,” David T. Rubin, M.D., director, Inflammatory Bowel Disease Center, University of Chicago Medicine, said in a news release.

Tremfya is also approved to treat patients with plaque psoriasis (2017) and active psoriatic arthritis (2020). The cost for Tremfya (100 mg/mL) subcutaneous solution is approximately $14,618, according to Drugs.com. For the full year 2023, Tremfya generated total worldwide revenue of $3.1 billion, up 18% from 2022.

J&J offers both $5 per injection and $0 copay programs for eligible commercially insured patients. In the terms for the copay assistance, J&J says that patients whose insurance companies apply accumulator or maximizer program are not eligible for the copay assistance.

The terms specifically identify programs offered by SaveOnSP, a company that help plans and self-insured employers and their members to access copay assistance. J&J has filed a lawsuit against SaveOnSP, saying that SaveOnSP plans “deplete” Janssen CarePath program for 44 of J&J medications. The suit alleges that SaveOnSP works “in partnership” with Express Scripts and its specialty pharmacy Accredo Health Group to artificially raise patient copays amounts to maximize profits for the PBM.

Tremfya’s ulcerative colitis approval was based on data from the phase 2b/3 QUASAR study. The study showed that 50% of patients who received Tremfya 200 mg subcutaneous (SC) maintenance every four weeks and 45% of patients who received Tremfya 100 mg SC every eight weeks achieved primary endpoint of clinical remission at week 44 compared with 19% placebo-treated patients.

Additionally, 34% of patients give the 200 mg dose and 35% of patients given the 100 mg of patients achieved endoscopic remission at one year compared with 15% placebo-treated patients.

For the ulcerative colitis indication, Tremfya is approved as 200 mg induction dose intravenously at weeks zero, four and eight by a healthcare professional. The recommended maintenance dose 100 mg administered by subcutaneous injection at week 16, and every 8 weeks thereafter, or 200 mg administered by subcutaneous injection at week 12, and every 4 weeks thereafter.

In June 2024, J&J submitted a supplemental application for Tremfya to treat patients with moderately to severely active Crohn’s disease. This submission based on results from the phase 3 GALAXI program, which was featured as a late-breaking oral presentation at Digestive Disease Week (DDW) last month.

In the GALAXI 2 and GALAXI 3 studies Tremfya met the co-primary endpoints for both SC maintenance doses (200 mg every 4 weeks and 100 mg every 8 weeks) compared with placebo and demonstrated superiority to Stelara (ustekinumab) in endoscopic endpoints based on data pooled from both studies.