JnJ submits regulatory applications to EMA for Tremfya for treatment of patients with ulcerative colitis, Crohn's disease

Guselkumab is the first approved fully-human monoclonal antibody that selectively binds to the p19 subunit of IL-23 and inhibits its interaction with the IL-23 receptor. 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 ulcerative colitis and Crohn’s disease. Guselkumab is approved in the European Union (EU) for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy and for the treatment of active psoriatic arthritis in adult patients who have had an inadequate response or who have been intolerant to a prior disease-modifying antirheumatic drug therapy.

“Inflammatory bowel disease, which includes ulcerative colitis and Crohn’s disease, affects as many as four million people in Europe annually,” said Ludovic de Beaucoudrey, PhD, Senior Director, Therapeutic Area Lead, Immunology, Janssen-Cilag Limited, a company of Johnson & Johnson. “We look forward to working closely with the EMA during review of these applications and are deeply committed to rapidly innovating for those patients who live with immune-mediated diseases like ulcerative colitis and Crohn’s disease where considerable needs remain.”

Clinical data from the Phase 3 QUASAR induction study through 12 weeks were presented at the 2023 Digestive Disease Week Annual Meeting and results from the Phase 3 QUASAR maintenance study through 44 weeks will be presented at an upcoming medical meeting. Clinical data from the long-term extension of the GALAXI Phase 2 study through three years were presented at United European Gastroenterology Week 2023 and results from the Phase 3 studies through 48 weeks will be presented at an upcoming medical meeting. 

In March 2024, Johnson & Johnson submitted a supplemental Biologics License Application to the U.S. Food and Drug Administration seeking approval of guselkumab for treatment of adults with moderately to severely active ulcerative colitis.