Johnson & Johnson announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking approval of TREMFYA® (guselkumab) for the treatment of adults with moderately to severely active Crohn's disease. This marks the second submission to the FDA for TREMFYA® in inflammatory bowel disease this year following an application in March for moderately to severely active ulcerative colitis. The latest submission includes results from the Phase 3 GALAXI program, which was featured as a late-breaking oral presentation at Digestive Disease Week (DDW) 2024 last month.

The GALAXI 2 and GALAXI 3 studies were the first-ever double-blind registrational head-to-head trials to demonstrate superiority versus ustekinumab in Crohn's disease. TREMFYA® successfully met the co-primary endpoints for both SC maintenance doses (200 mg every 4 weeks [q4w] and 100 mg every 8 weeks [q8w]) compared to placebo in each individual study and demonstrated superiority to ustekinumab in multiplicity-controlled endoscopic endpoints based on data pooled from both studies. The submission also includes results from the Phase 3 GRAVITI investigational study of TREMFYA ® SC induction therapy in adult patients with moderately to severely active Crohn's disease, which met the co-primary endpoints, achieving statistically significant and clinically meaningful outcomes for clinical remission at Week 12 as well as endoscopic response at Week 12.

In addition, all multiplicity-controlled endpoints were met compared to placebo at Week 12, Week 24 and Week 48. The results from GALAXI and GRAVITI show that TREMFYA® has the potential to become the only IL-23 inhibitor to offer both subcutaneous or intravenous induction options for the treatment of Crohn's disease, and, if approved, will offer choice and versatility for patients and providers. TREMFYA® is the first approved 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 secreted by activated monocyte/macrophages and dendritic cells that is known to be a driver of immune-mediated diseases including Crohn's disease. TREMFYA®, the first-in-class IL-23 inhibitor, received U.S. FDA approval in July 2017 for the treatment of adult patients with moderate-to-severe plaque psoriasis and was subsequently approved for adults with active psoriatic arthritis in July 2020. Janssen-Cilag International NV, a Johnson & Johnson company, previously announced  the submission of applications to the European Medicines Agency (EMA) seeking to expand the Marketing Authorization Application for TREMFYA® to include the treatment of adult patients with moderately to severely active ulcerative colitis and moderately to severely active Crohn's disease.