Johnson & Johnson Seeks FDA Approval for Subcutaneous TREMFYA® in Ulcerative Colitis
Key Insights
Johnson & Johnson has submitted an sBLA to the FDA for a subcutaneous induction regimen of TREMFYA® (guselkumab) for treating moderately to severely active ulcerative colitis (search).
The submission is based on the Phase 3 ASTRO study, which met its primary endpoint of clinical remission at Week 12 using a 400 mg subcutaneous induction dose.
TREMFYA®, an IL-23 (search) inhibitor, could become the first in its class to offer both subcutaneous and intravenous induction options for ulcerative colitis (search) patients.
Johnson & Johnson (J&J) has announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for TREMFYA® (guselkumab) seeking approval of a subcutaneous (SC) induction regimen for adult patients with moderately to severely active ulcerative colitis (search) (UC). This submission is supported by positive data from the Phase 3 ASTRO study, potentially positioning TREMFYA® as the first IL-23 (search) inhibitor with both SC and IV induction options for UC.
The Phase 3 ASTRO study evaluated 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. The study achieved its primary endpoint, demonstrating statistically significant and clinically meaningful clinical remission at Week 12.
ASTRO Study Details
The ASTRO study is a randomized, double-blind, placebo-controlled, parallel-group, multicenter, treat-through Phase 3 study. Patients were randomized 1:1:1 to receive TREMFYA® 400 mg SC induction at Weeks 0, 4 and 8 followed by TREMFYA® 200 mg SC every 4 weeks; or TREMFYA® 400 mg SC induction at Weeks 0, 4 and 8, followed by TREMFYA® 100 mg SC every 8 weeks; or placebo. All secondary endpoints, including endoscopic improvement and histologic-endoscopic mucosal improvement (HEMI), were also met. The safety profile observed in the ASTRO study was consistent with previous findings from the QUASAR program.
Esi Lamousé-Smith, M.D., Ph.D., Vice President, Gastroenterology Disease Area Lead, Immunology, Johnson & Johnson Innovative Medicine, stated, “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.”
TREMFYA® Mechanism of Action
TREMFYA® is a dual-acting monoclonal antibody that selectively blocks IL-23 (search) and binds to CD64, a receptor on cells that produce IL-23. IL-23 is a cytokine involved in immune-mediated diseases, including UC. TREMFYA® received FDA approval in September 2024 for treating adult patients with moderately to severely active UC, administered via an IV induction regimen followed by SC maintenance.
Ulcerative Colitis and TREMFYA®
Ulcerative colitis (search) is a chronic inflammatory condition of the large intestine, characterized by inflammation and ulcers in the colon's lining. Symptoms include urgent bowel movements, rectal bleeding, persistent diarrhea, and abdominal pain. TREMFYA® offers a targeted approach by neutralizing IL-23 (search), a key driver of inflammation in UC.
Johnson & Johnson has also submitted an application seeking approval of TREMFYA® for the treatment of adults with moderately to severely active Crohn’s disease (search) in the U.S., and applications seeking approval for both CD and UC have been submitted in Europe.