FDA Approves J&J TREMFYA for Pediatric Psoriasis Arthritis

Johnson & Johnson has received FDA approval for TREMFYA (guselkumab) to treat children aged six and older who weigh at least 40 kg with moderate to severe plaque psoriasis or active psoriatic arthritis, marking it as the first IL-23 inhibitor approved for these pediatric conditions. This expands on previous FDA approvals for adults with these conditions, first granted in 2017 and 2020 respectively. The approval is backed by clinical data including the Phase 3 PROTOSTAR study, which demonstrated significant skin clearance and symptom improvement in pediatric patients. TREMFYA is administered via subcutaneous injection and has shown a favorable safety profile, with common adverse events being mostly mild, such as upper respiratory tract infections. The drug targets IL-23, a cytokine involved in immune-mediated diseases, and offers a new treatment option for roughly 20,000 children diagnosed annually with plaque psoriasis and about 14,000 children with psoriatic arthritis. Experts highlight the approval as a vital advancement addressing a previously unmet need in pediatric immune-mediated disease treatment.