HORSHAM, PA — Johnson & Johnson (NYSE: JNJ) has submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration, seeking approval to update the labeling for TREMFYA® (guselkumab) based on new clinical evidence showing its ability to slow joint damage in adults with active psoriatic arthritis (PsA).
The filing is backed by data from the Phase 3b APEX study, which demonstrated that TREMFYA® met both its primary and key secondary endpoints. Specifically, the treatment reduced joint symptoms and significantly inhibited the progression of structural damage over a 24-week period, as measured by changes in the modified van der Heijde-Sharp (vdH-S) score. The trial involved biologic-naïve patients and was presented at the 2025 European Alliance of Associations for Rheumatology (EULAR) Congress.
“Psoriatic arthritis is a complex disease that can lead to severe and irreversible joint damage, which is why we are dedicated to developing innovative therapies that comprehensively address the long-term impact as well as the everyday challenges of this condition,” said Brandee Pappalardo, Ph.D., M.P.H., Vice President of Medical Affairs for Dermatology & Rheumatology at Johnson & Johnson Innovative Medicine. “With this new evidence, TREMFYA® would become the first and only IL-23 inhibitor proven to provide symptom control and to significantly inhibit the progression of joint damage in patients living with active PsA.”
The safety outcomes in the APEX trial were consistent with the established safety profile of TREMFYA®, reinforcing its track record in PsA treatment. Additional data are expected to be shared at upcoming medical conferences.
TREMFYA® is currently the only fully-human, dual-acting monoclonal antibody approved to treat psoriatic arthritis. It targets both IL-23—a key cytokine involved in driving immune-mediated inflammation—and CD64, a receptor on IL-23-producing immune cells. This dual mechanism is designed to provide comprehensive disease control, including both symptom relief and protection against long-term joint deterioration.
If the FDA grants approval for the label update, TREMFYA® could become a more prominent therapeutic option for physicians aiming to manage both the symptoms and the structural progression of PsA.
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