Johnson & Johnson Seeks FDA Approval for TREMFYA in Treating Crohn’s Disease

Johnson & Johnson

SPRING HOUSE, PAJohnson & Johnson (NYSE: JNJ) has submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for the approval of TREMFYA® (guselkumab) to treat adults with moderately to severely active Crohn’s disease. This is the second FDA submission this year for TREMFYA® related to inflammatory bowel disease, following an application in March for ulcerative colitis.

The recent submission includes results from the Phase 3 GALAXI program, highlighted at Digestive Disease Week 2024. The GALAXI 2 and GALAXI 3 studies were the first registrational trials to show superiority over ustekinumab in Crohn’s disease. TREMFYA® met the primary endpoints for both maintenance doses (200 mg every four weeks and 100 mg every eight weeks) compared to placebo in each study, and demonstrated superior efficacy in endoscopic outcomes when the data from both studies were combined.

Additionally, the submission features findings from the Phase 3 GRAVITI study of TREMFYA® in induction therapy for Crohn’s disease. This study also met its primary endpoints, showing significant clinical remission and endoscopic response at Week 12. All controlled endpoints were achieved at Week 12, 24, and 48, indicating consistent efficacy over time. If approved, TREMFYA® would become the only IL-23 inhibitor offering both subcutaneous and intravenous induction options for Crohn’s disease, providing more flexibility for patients and healthcare 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 Dr. David Lee, Global Therapeutic Area Head, Immunology at Johnson & Johnson Innovative Medicine. “TREMFYA has the potential to be a differentiated treatment option for patients seeking 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.”

READ:  Boomi Launches API Control Plane to Boost Innovation and Governance

TREMFYA® is a fully-human monoclonal antibody that blocks IL-23 and binds to CD64, a receptor on cells that produce IL-23. IL-23 is a cytokine involved in immune-mediated diseases, including Crohn’s disease. TREMFYA® received FDA approval in July 2017 for moderate-to-severe plaque psoriasis and in July 2020 for active psoriatic arthritis.

For the latest news on everything happening in Chester County and the surrounding area, be sure to follow MyChesCo on Google News and Microsoft Start.