Johnson & Johnson Seeks FDA Approval for TREMFYA Psoriatic Arthritis Label Update

Johnson & Johnson has submitted a supplemental Biologics License Application to the U.S. FDA seeking approval to update the label for TREMFYA® (guselkumab) to include new clinical evidence showing its ability to slow joint damage in adults with active psoriatic arthritis. The application is supported by data from the Phase 3b APEX study, which demonstrated that TREMFYA® met its primary endpoint of reducing joint symptoms and a key secondary endpoint of significantly inhibiting structural damage progression over 24 weeks in biologic-naïve patients. TREMFYA® would become the first and only IL-23 inhibitor proven to provide both symptom control and significant inhibition of joint damage progression in psoriatic arthritis, according to Johnson & Johnson. The safety profile observed in the APEX trial was consistent with prior data, reinforcing TREMFYA®’s established safety in PsA treatment. TREMFYA® is a fully-human, dual-acting monoclonal antibody targeting IL-23 and CD64, addressing immune-mediated inflammation in PsA. Additional data from the trial are expected to be presented at upcoming medical conferences.