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# J&J Seeks Label Update on Tremfya
- URL: https://www.fdaweb.com/j-j-seeks-label-update-on-tremfya/
- Published: 2025-07-29T12:00:00.000Z
- Updated: 2026-09-14T15:17:46.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5159583

Johnson & Johnson has submitted a supplemental BLA seeking to update the prescribing information for Tremfya (guselkumab) to include new data demonstrating its ability to inhibit structural joint damage in adults with active psoriatic arthritis (PsA). The submission is based on 24-week results from the Phase 3b APEX placebo controlled study, which met its primary goal of reducing joint symptoms — measured by the American College of Rheumatology 20% improvement criteria (ACR20) — and also met a key secondary endpoint by significantly slowing progression of structural damage, as assessed by the modified van der Heijde-Sharp (vdH-S) score, when compared to placebo.

The company describes Tremfya as the only approved therapy for PsA that blocks interleukin-23 (IL-23) while also binding to CD64, a receptor on cells that produce IL-23\. It says IL-23 is a key cytokine involved in driving inflammation in immune-mediated diseases, including PsA.