Posted by Michael Wonder on 12 Mar 2024
Johnson & Johnson submits supplemental biologics license application to US FDA seeking approval of Tremfya (guselkumab) for the treatment of adults with moderately to severely active ulcerative colitis
11 March 2024 - Submission is supported by data from the Phase 3 QUASAR program, which showed a significantly greater percentage of patients with moderately to severely active ulcerative colitis who received Tremfya achieved clinical remission at week 44 compared with placebo.
Johnson & Johnson today announced the submission of a supplemental biologics license application to the US FDA seeking approval of Tremfya (guselkumab) for treatment of adults with moderately to severely active ulcerative colitis.
