Janssen-Cilag Seeks EMA Approval for Guselkumab in Ulcerative Colitis and Crohn’s Disease
Janssen-Cilag International NV, a subsidiary of Johnson & Johnson, has submitted applications to the European Medicines Agency (EMA) to expand the Marketing Authorization Application for TREMFYA® (guselkumab) for the treatment of adult patients with moderately to severely active ulcerative colitis and Crohn’s disease. The submission is supported by data from the Phase 3 QUASAR program for ulcerative colitis and the Phase 3 GALAXI program for Crohn’s disease, demonstrating significant improvements in symptoms and disease activity. Safety results were consistent with the known safety profile of guselkumab. Dr. David Lee, Global Therapeutic Area Head Immunology, emphasized the need for effective therapies for these chronic, immune-mediated diseases. Guselkumab, the first fully-human monoclonal antibody targeting the p19 subunit of IL-23, has already been approved in the EU for other indications. Ludovic de Beaucoudrey, Senior Director, Therapeutic Area Lead, Immunology at Janssen-Cilag Limited, highlighted the significant impact of inflammatory bowel diseases in Europe and expressed commitment to innovation for patients with immune-mediated diseases.