JnJ seeks USFDA approval for Tremfya for moderately to severely active Crohn's disease
Spring House: Johnson & Johnson has 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 thetreatment 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.
“Building upon nearly three decades of leadership and innovation in immunology, we are committed to addressing the needs of people living with Crohn’s disease through deep, scientific expertise and through our continued pioneering advances in the IL-23 pathway,” said David Lee, M.D., Ph.D., Global Therapeutic Area Head Immunology, Johnson & Johnson Innovative Medicine. “TREMFYA has the potential to be a differentiated treatment option for patients who seek symptom relief and sustained remission. We look forward to working with the Agency in their review of the data supporting the application as we continue to innovate for people living with inflammatory bowel disease.”
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.
