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 a subcutaneous (SC) induction regimen of TREMFYA® (guselkumab) for the treatment of adults with moderately to severely active ulcerative colitis (UC). This submission is based on data from the Phase 3 ASTRO study and aims to expand the treatment options for patients with UC.
The Phase 3 ASTRO study demonstrated that TREMFYA® SC induction therapy, administered at a dose of 400 mg at Weeks 0, 4, and 8, achieved statistically significant and clinically meaningful results for clinical remission at Week 12. The study also met all secondary endpoints, including endoscopic improvement and histologic-endoscopic mucosal improvement (HEMI). The safety data from ASTRO were consistent with the safety findings from the QUASAR program.
Potential Impact on IBD Treatment
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 (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 inhibitor to potentially offer a fully SC induction and maintenance regimen, which if approved, can provide choice and simplicity for patients and providers."
About the ASTRO Study
The ASTRO study (NCT05528510) is a Phase 3 randomized, double-blind, placebo-controlled, parallel-group, multicenter study. It evaluated the efficacy and safety of TREMFYA® SC induction therapy (400 mg at Weeks 0, 4, and 8) in adults with moderately to severely active ulcerative colitis who had an inadequate response or intolerance to conventional therapy, prior biologics, and/or approved JAK inhibitors. Patients were randomized to receive TREMFYA® 400 mg SC induction followed by TREMFYA® 200 mg SC q4w, TREMFYA® 400 mg SC induction followed by TREMFYA® 100 mg SC q8w, or placebo.
About TREMFYA® (guselkumab)
TREMFYA® is a dual-acting monoclonal antibody that blocks IL-23 and binds to CD64, a receptor on cells that produce IL-23. It is approved in the U.S. for treating adults with moderate to severe plaque psoriasis, active psoriatic arthritis, and moderately to severely active ulcerative colitis. J&J maintains exclusive worldwide marketing rights to TREMFYA®.
Ulcerative Colitis and Current Treatment Landscape
Ulcerative colitis is a chronic disease of the large intestine characterized by inflammation and ulcers. Symptoms include urgent bowel movements, rectal bleeding, and abdominal pain. TREMFYA's recent approval for UC was supported by the Phase 3 QUASAR study, which evaluated its efficacy and safety in adults with moderately to severely active UC. The current treatment involves an IV induction regimen followed by a SC maintenance regimen.
