Posted by Michael Wonder on 02 May 2024
Johnson & Johnson submits regulatory applications to EMA for Tremfya (guselkumab) for treatment of patients with ulcerative colitis and Crohn’s disease
1 May 2024 - Submission included data from the Phase 3 QUASAR program in ulcerative colitis and the Phase 3 GALAXI program in Crohn’s disease, which each achieved their primary endpoints.
Janssen-Cilag today announced it has submitted applications to the EMA seeking to expand the marketing authorisation 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.
