, /PRNewswire/ -- Johnson & Johnson (NYSE: ) today 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 in March for moderately to severely active ulcerative colitis. The latest submission includes results from the Phase 3 GALAXI program, which 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 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 m.