J&J Seeks FDA Approval for Subcutaneous TREMFYA® Induction in Ulcerative Colitis
Key Insights
Johnson & Johnson has submitted an application to the FDA for a subcutaneous induction regimen of TREMFYA® (guselkumab) for ulcerative colitis (search).
The application is based on the Phase 3 ASTRO study, which met its primary endpoint of clinical remission at Week 12 with statistical significance.
TREMFYA® is currently approved for UC with an IV induction, followed by SC maintenance, and this new regimen could offer a fully SC option.
Johnson & Johnson has announced the submission of an application to the U.S. Food and Drug Administration (FDA) seeking approval for a subcutaneous (SC) induction regimen of TREMFYA® (guselkumab) for the treatment of adults with moderately to severely active ulcerative colitis (search) (UC). This application marks a significant step toward potentially offering the first fully SC induction and maintenance regimen for an IL-23 (search) inhibitor in UC.
The application is supported by data from the Phase 3 ASTRO study, a randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of TREMFYA® SC induction therapy (400 mg at Weeks 0, 4, and 8) in adults with moderately to severely active UC who had an inadequate response or intolerance to conventional therapy, prior biologics, and/or approved JAK inhibitors. The study met its primary endpoint, demonstrating statistically significant and clinically meaningful results for clinical remission at Week 12.
ASTRO Study Details
The ASTRO study randomized patients 1:1:1 to receive one of the following regimens:
- TREMFYA® 400 mg SC induction at Weeks 0, 4, and 8, followed by TREMFYA® 200 mg SC every 4 weeks.
- TREMFYA® 400 mg SC induction at Weeks 0, 4, and 8, followed by TREMFYA® 100 mg SC every 8 weeks.
- Placebo.
Notably, the maintenance doses used in the ASTRO study (200 mg SC q4w and 100 mg SC q8w) mirror those evaluated in the Phase 3 QUASAR program, which previously established the efficacy and safety of intravenous (IV) induction followed by SC maintenance therapy in UC patients.
Clinical Significance
"With the ASTRO study in UC and the GRAVITI study in Crohn's disease (search) (CD), we are focused on delivering versatility and options for administration of treatment for people with inflammatory bowel disease (IBD). TREMFYA is the first IL-23 (search) inhibitor to potentially offer a fully SC induction and maintenance regimen, which if approved, can provide choice and simplicity for patients and providers," stated Esi Lamousé-Smith, M.D., Ph.D., Vice President, Gastroenterology Disease Area Lead, Immunology, Johnson & Johnson Innovative Medicine. "The ASTRO results add to the compelling data generated from the QUASAR program in UC and build on the promise of TREMFYA in the treatment of IBD as we look to transform outcomes for patients."
Current Treatment Landscape
TREMFYA® received U.S. FDA approval in September 2024 for the treatment of adult patients with moderately to severely active UC and is currently administered via an IV induction regimen, followed by a SC maintenance regimen. The approval was supported by data from the Phase 3 QUASAR study evaluating the efficacy and safety of TREMFYA® in adults with moderately to severely active UC.
Ulcerative Colitis and TREMFYA®
Ulcerative colitis (search) is a chronic disease affecting the large intestine, characterized by inflammation and ulcers in the colon lining. Symptoms can include urgent bowel movements, rectal bleeding, persistent diarrhea, and abdominal pain. TREMFYA® is a fully-human, dual-acting monoclonal antibody that neutralizes inflammation by blocking IL-23 (search) and binding to CD64. It is already approved for plaque psoriasis, psoriatic arthritis, and ulcerative colitis.
Johnson & Johnson maintains exclusive worldwide marketing rights to TREMFYA®.