Johnson & Johnson has submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for TREMFYA (guselkumab).

The filing seeks to update the label with new data showing TREMFYA significantly inhibits joint structural damage in adults with active psoriatic arthritis (PsA), making it the first IL-23 inhibitor to demonstrate this effect.

The submission is supported by results from the Phase 3b APEX study, which met both its primary endpoint (ACR20) and a key secondary endpoint: inhibition of joint damage progression, measured by modified van der Heijde-Sharp (vdH-S) score at week 24 in biologic-naïve patients. These results were recently presented at the EULAR 2025 Congress.

“Psoriatic arthritis can cause irreversible joint damage. This new evidence underscores TREMFYA’s ability to provide symptom relief and also help prevent long-term damage,” said Brandee Pappalardo, Ph.D., M.P.H., VP, Medical Affairs, Dermatology & Rheumatology, Johnson & Johnson Innovative Medicine.

TREMFYA is the first fully human, dual-acting monoclonal antibody for PsA that blocks IL-23 and binds to CD64, a receptor on IL-23-producing cells.