On 22 November 2024, Johnson & Johnson submitted a supplemental Biologics License Application to the FDA seeking approval of a subcutaneous (SC) induction regimen of Tremfya® (guselkumab) for the treatment of adults with moderately to severely active ulcerative colitis (UC). The filing is supported by data from the Phase 3 ASTRO study (NCT05528510).
This follows the recent approval of Tremfya® in the US for UC, with an intravenous induction dose followed by subcutaneous maintenance (September 2024). Tremfya® is also under consideration for approval for UC in Australia and Europe.