Johnson & Johnson has announced that the U.S. Food and Drug Administration (FDA) has approved its biologic therapy TREMFYA® (guselkumab) for use in children aged six years and older who weigh at least 40 kg and suffer from moderate to severe plaque psoriasis (PsO) or active psoriatic arthritis (PsA). This makes TREMFYA the first and only IL-23 inhibitor approved for pediatric patients with these conditions.
The approval provides a much-needed treatment option for an estimated 20,000 children under age 10 diagnosed annually with plaque psoriasis, as well as around 14,000 children affected by psoriatic arthritis. Both conditions are chronic and can be physically painful and emotionally distressing, particularly in younger patients. Psoriasis can cause inflamed, itchy plaques on the skin, while PsA includes joint inflammation and swelling, potentially impairing a child’s mobility and wellbeing.
The decision was supported by data from the Phase 3 PROTOSTAR trial in pediatric plaque PsO patients, along with adult studies including VOYAGE 1 and 2. In PROTOSTAR, TREMFYA demonstrated significant skin clearance by Week 16, with 56% of patients achieving PASI 90 (a 90% reduction in psoriasis severity) versus 16% in the placebo group. Additionally, 66% of patients achieved clear or almost clear skin, and nearly 40% experienced complete clearance.
Approval for pediatric PsA was based on pharmacokinetic extrapolation from adult studies, which confirmed the safety and efficacy of TREMFYA across age groups.
“Despite advancements in the treatment of pediatric plaque psoriasis and active psoriatic arthritis, there continues to be a significant gap in available therapies,” said Dr. Vimal Hasmukh Prajapati, a clinical associate professor and study investigator. “TREMFYA offers a well-established treatment with proven efficacy that can improve the lives of affected children.”
TREMFYA is administered via subcutaneous injection at Week 0, Week 4, and then every eight weeks. The recommended dose is 100 mg using a 1 mL prefilled syringe.
Brandee Pappalardo, PhD, MPH, Vice President of Medical Affairs at Johnson & Johnson Innovative Medicine, noted that the approval is a major step forward not just for children, but also for their caregivers. “Every child deserves to feel comfortable in their own skin and to be active without limitations,” she said.
Leah M. Howard, President and CEO of the National Psoriasis Foundation, welcomed the news, highlighting the emotional toll these conditions can have. “This approval brings hope for relief from the pain and emotional burden of these diseases,” she said.
TREMFYA is the only fully-human, dual-acting monoclonal antibody that blocks IL-23 and binds to CD64, a key receptor on immune cells. Johnson & Johnson continues to explore its broader use in other immune-mediated diseases, including ulcerative colitis and Crohn’s disease.