Janssen-Cilag International NV, a Johnson & Johnson company, today announced it has submitted applications to the European Medicines Agency (EMA) seeking to expand the Marketing Authorization Application for TREMFYA® (guselkumab) to include the treatment of adult patients with moderately to severely active ulcerative colitis and moderately to severely active Crohn’s disease.
The submission included data from the Phase 3 QUASAR programme in ulcerative colitis and the Phase 3 GALAXI programme 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 programme, guselkumab achieved co-primary endpoints demonstrating statistically significant and clinically meaningful improvements relative to placebo in clinical remission and endoscopic response. Safety results were consistent with the known safety profile of guselkumab in approved indications.
“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 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.”
Guselkumab is the first approved fully-human monoclonal antibody that blocks IL-23 by binding to the p19 subunit of 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 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.
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. 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.”
David Lee, MD, PhD, Global Therapeutic Area Head Immunology, Johnson & Johnson Innovative Medicine
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 GALAXI 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.
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