HORSHAM, PA — The U.S. Food and Drug Administration has approved a label expansion for Johnson & Johnson’s (NYSE: JNJ) TREMFYA, allowing the company to market clinical evidence showing the drug inhibits progression of structural joint damage in adults with active psoriatic arthritis, a development that could strengthen the treatment’s competitive position in the autoimmune disease market.
The approval adds findings from the Phase 3b APEX trial to TREMFYA’s prescribing information and provides physicians with FDA-recognized evidence that the therapy can slow irreversible joint damage in addition to controlling disease symptoms.
The label update is supported by 24-week results from the APEX study, which evaluated TREMFYA in biologic-naïve patients with active psoriatic arthritis. Johnson & Johnson said the trial met its primary endpoint for reducing joint symptoms and a major secondary endpoint measuring inhibition of structural joint damage compared with placebo.
According to the company, 48-week data also showed patients who initially received placebo and switched to TREMFYA at Week 24 experienced a 57% reduction in radiographic disease progression during the subsequent 24 weeks.
“Joint damage associated with active psoriatic arthritis can happen as soon as six months after onset of disease, so it’s important to have treatment solutions that can help provide daily symptom relief while also protecting joints from long-term structural damage,” said Dr. Philip J. Mease, director of rheumatology research at Swedish Medical Center/Providence St. Joseph Health and a clinical professor at the University of Washington School of Medicine.
Psoriatic arthritis is a chronic inflammatory condition that can lead to permanent joint damage if left untreated. Johnson & Johnson cited estimates indicating that as many as half of patients with active disease may develop early irreversible damage.
The company said no new safety signals were identified during the APEX study, with results remaining consistent with TREMFYA’s established safety profile.
“With the inclusion of these findings in the label, we now have stronger clinical evidence that sets TREMFYA apart as a treatment option for patients with active psoriatic arthritis at risk for joint damage,” Mease said.
TREMFYA is approved to treat psoriatic arthritis and several other immune-mediated diseases, including plaque psoriasis, ulcerative colitis, and Crohn’s disease. The therapy works by targeting interleukin-23, a cytokine involved in inflammatory processes associated with multiple autoimmune conditions.
The FDA decision provides Johnson & Johnson with an additional clinical claim in a competitive market for biologic therapies targeting inflammatory diseases, where manufacturers increasingly seek differentiated efficacy data to support prescribing decisions.
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