Posted by Michael Wonder on 30 Nov 2024
Johnson & Johnson seeks US FDA approval for subcutaneous induction regimen of Tremfya (guselkumab) in ulcerative colitis, a first for an IL-23 inhibitor
22 November 2024 - Submission is supported by the Phase 3 ASTRO study, which achieved the primary endpoint of clinical remission at Week 12 and met all secondary endpoints in adults with moderately to severely active ulcerative colitis.
Johnson & Johnson today announced the submission of a supplemental biologics license application to the US FDA seeking approval of a subcutaneous induction regimen of Tremfya (guselkumab) for the treatment of adults with moderately to severely active ulcerative colitis.
