J&J Submits sBLA to US FDA for Approval of Guselkumab

J&J Submits sBLA to US FDA for Approval of Guselkumab

By, Admin 24 June 2024

J&J submits sBLA to US FDA seeking approval of guselkumab to treat moderately to severely active Crohn's disease

Overview

Johnson & Johnson has announced the submission of a supplemental Biologics License Application (sBLA) to the US 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 US FDA for Tremfya in inflammatory bowel disease this year following an application in March for moderately to severely active ulcerative colitis.

Phase 3 GALAXI Program

  • 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 compared to placebo in each individual study and demonstrated superiority to ustekinumab in multiplicity-controlled endoscopic endpoints based on data pooled from both studies.

Phase 3 GRAVITI Investigational Study

  • 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.

From Johnson & Johnson Innovative Medicine

  • "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, 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: a Dual-Acting Monoclonal Antibody

  • 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 US 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.

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