HORSHAM, PA, (September 29, 2025) – Johnson & Johnson (NYSE: JNJ) today announced that the U.S. Food and Drug Administration (FDA) has approved TREMFYA® (guselkumab) for the treatment of children six years and older who also weigh at least 40 kg with moderate to severe plaque psoriasis (PsO), who are candidates for systemic therapy or phototherapy, or active psoriatic arthritis (PsA). This milestone makes TREMFYA® the first and only IL-23 inhibitor approved for these pediatric indications and builds on the initial FDA approvals in adults living with moderate to severe plaque PsO in 2017 and active PsA in 2020.
These approvals for TREMFYA® offer important new treatment options for the roughly 20,000 children under 10 diagnosed with plaque PsO annually and the approximately 14,000 children impacted by PsA.1,2,3 One-third of PsO cases begin in childhood and the inflamed, scaly plaques caused by the chronic disease may be itchy or painful and can be highly stressful for children, leading to a potential long-term impact on those affected.4 Active PsA accounts for approximately five percent of the juvenile idiopathic arthritis population and is characterized by chronic joint inflammation, swelling and PsO, potentially impacting a child’s physical ability and overall wellbeing.5
“Despite advancements in the treatment of pediatric plaque psoriasis and active psoriatic arthritis, there continues to be a significant gap in available therapies for these debilitating immune-mediated diseases that impact a child’s physical and emotional wellbeing during critical years,” said Vimal Hasmukh Prajapati, M.D., Clinical Associate Professor, University of Calgary, Councilor for the International Psoriasis Council, as well as Co-Founder and Co-Director of the Skin Health & Wellness Centre, Dermatology Research Institute, and Dermphi Centre, and study investigator. “The approval of TREMFYA offers physicians, as well as parents and care partners, an established treatment option with proven safety and demonstrated efficacy that can significantly improve the signs and symptoms in children living with these diseases.”
The plaque PsO approval was based on results from the Phase 3 PROTOSTAR study in pediatric patients with moderate to severe plaque PsO and supportive data from the Phase 3 VOYAGE 1 and 2 studies in adult patients with moderate to severe plaque PsO. In the PROTOSTAR study, the co-primary endpoints of Psoriasis Area Severity Index (PASI) 90 and Investigator’s Global Assessment (IGA) score of 0/1 were achieved at Week 16. Approximately 56% of patients receiving TREMFYA® achieved PASI 90, compared to 16% of patients receiving placebo (p<0.01). At Week 16, 66% of patients receiving TREMFYA® compared to 16% of patients receiving placebo (p<0.001) achieved high levels of skin clearance (IGA score of 0/1). Nearly 40% of pediatric patients receiving TREMFYA® achieved complete clearance (IGA 0) at Week 16 compared to 4% on placebo (p<0.01).6
Approval of the active PsA indication was supported by evidence from pharmacokinetic extrapolation analyses from TREMFYA® PsO and PsA studies, including VOYAGE 1 and 2, DISCOVER 1 and 2 and PROTOSTAR. Findings from these analyses corroborate the efficacy and safety data from adults with PsO and PsA and children with moderate to severe plaque PsO to children with active PsA.
“Every child deserves to feel comfortable in their own skin and to be active without the limitations of joint pain, stiffness and swelling,” said Brandee Pappalardo, PhD, MPH, Vice President, Medical Affairs, Dermatology & Rheumatology, Johnson & Johnson Innovative Medicine. “The approval of the first and only pediatric indications for an IL-23 inhibitor marks an important step forward not only for children, but also for the parents and care partners who support them every day. We remain committed to advancing research that demonstrates the long-term safety and efficacy of TREMFYA and to exploring its full potential for adult and pediatric patients.”
