Johnson & Johnson today announced a landmark approval from the U.S. Food and Drug Administration: TREMFYA® (guselkumab) is now cleared for use in children aged 6 years and older (minimum 40 kg body weight) with moderate to severe plaque psoriasis, and in pediatric patients with active psoriatic arthritis. This approval marks TREMFYA as the first and only IL-23 inhibitor approved for these pediatric indications.
According to a September 29, 2025, press release from the company, the FDA’s decision makes guselkumab the first and only IL-23 inhibitor approved for pediatric plaque psoriasis and psoriatic arthritis. This milestone builds on TREMFYA’s earlier approvals for adults with moderate to severe plaque psoriasis in 2017 and active psoriatic arthritis in 2020.
The FDA’s decision is supported by safety and efficacy data from the Phase 3 PROTOSTAR trial in children with plaque psoriasis, alongside evidence from adult studies and extrapolated data for pediatric psoriatic arthritis. In PROTOSTAR, co-primary endpoints included IGA 0/1 (clear or almost-clear skin) and PASI 90 (90% improvement in skin lesions) at Week 16.
Results showed that ~56% of children treated with TREMFYA reached PASI 90 versus ~16% in the placebo group. Similarly, 66% achieved IGA 0/1 compared with 16% on placebo, and nearly 40% attained complete clearance (IGA 0), compared to only 4% in the placebo arm.
For pediatric psoriatic arthritis, the approval relied on pharmacokinetic and pharmacodynamic extrapolation from adult and pediatric data, minimizing the need for large stand-alone pediatric trials while ensuring consistent efficacy and safety profiles.
Clinicians and researchers welcomed the FDA’s decision, highlighting the urgent need for more biologic treatment options for children living with chronic inflammatory skin and joint diseases. With the updated labeling, children will now receive subcutaneous injections at Week 0, Week 4, and every 8 weeks thereafter, mirroring the adult dosing schedule.
Johnson & Johnson emphasized that this approval not only expands TREMFYA’s reach but also strengthens its leadership in immunology and pediatric care. The company noted it remains committed to ongoing safety monitoring and to exploring broader pediatric applications for guselkumab.