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

The submission included data from the Phase 3 QUASAR program in ulcerative colitis and the Phase 3 GALAXI program in Crohn’s disease. In the Phase 3 QUASAR induction and maintenance studies, guselkumab achieved each primary endpoint and showed statistically significant and clinically meaningful improvements relative to placebo in symptoms, measures of disease activity including stringent endpoints such as endoscopic normalization and histo-endoscopic mucosal healing, and patient-reported outcomes such as fatigue. The safety results were consistent with the known safety profile of guselkumab in approved indications.

In the Phase 3 GALAXI 2 and 3 studies, guselkumab achieved co-primary endpoints at Week 12 and demonstrated statistically significant and clinically meaningful improvements relative to placebo in corticosteroid free clinical remission and endoscopic response at Week 48. Safety results were consistent with the known safety profile of guselkumab in approved indications.

“People living with chronic, immune-mediated disease such as ulcerative colitis and Crohn’s disease often spend a considerable amount of time cycling from one treatment to another in search of relief and sustained remission,” said David Lee, MD, PhD, Global Therapeutic Area Head Immunology. “This submission is an important step in our mission to develop novel, effective therapies for the millions of people worldwide living with ulcerative colitis and Crohn’s disease who are experiencing persistent and debilitating symptoms.”

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.