Horsham, Pa., Sept. 29, 2025 – The U.S. Food and Drug Administration (FDA) has granted approval for TREMFYA® (guselkumab) to treat pediatric patients aged six years and older, weighing at least 40 kg, with moderate to severe plaque psoriasis or active psoriatic arthritis. This approval makes TREMFYA® the first and only IL-23 inhibitor approved for these pediatric indications, expanding on Johnson & Johnson’s adult approvals for plaque psoriasis in 2017 and active psoriatic arthritis in 2020.
Science Significance
TREMFYA® is a fully-human, dual-acting monoclonal antibody that blocks IL-23 and binds to CD64, a receptor on cells producing IL-23. IL-23 is a key driver of immune-mediated diseases, including psoriasis, psoriatic arthritis, ulcerative colitis, and Crohn’s disease. The pediatric plaque psoriasis approval was based on the Phase 3 PROTOSTAR study, where 56% of patients achieved PASI 90 and 66% achieved high levels of skin clearance (IGA 0/1) by Week 16, compared to 16% on placebo. Nearly 40% of pediatric patients achieved complete clearance (IGA 0).
For pediatric psoriatic arthritis, approval relied on pharmacokinetic extrapolation from adult and pediatric studies, demonstrating TREMFYA®’s efficacy and safety for children. Experts note that this represents a significant advancement in pediatric immunology, providing a targeted therapy for chronic conditions that affect both skin and joints.
Regulatory Significance
The FDA approval highlights a major milestone in pediatric drug development. Pediatric populations are often underrepresented in clinical trials, and TREMFYA®’s approval relied on direct pediatric data from PROTOSTAR and supportive extrapolated adult trial data (VOYAGE 1 & 2, DISCOVER 1 & 2). This demonstrates regulatory confidence in mechanism-based extrapolation, enabling safe and effective therapies for children with rare immune-mediated diseases. TREMFYA® now sets a precedent as the first IL-23 inhibitor approved for pediatric indications, signaling regulatory support for innovative pediatric trial designs.
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Business Significance
This approval strengthens Johnson & Johnson’s pediatric immunology portfolio, providing new treatment options for approximately 20,000 children annually diagnosed with plaque psoriasis and 14,000 with active psoriatic arthritis. TREMFYA®’s pediatric launch enhances the company’s market position in IL-23 targeted therapies, complementing existing adult indications for psoriasis, psoriatic arthritis, ulcerative colitis, and Crohn’s disease. With exclusive worldwide marketing rights, Johnson & Johnson is poised to consolidate its leadership in innovative biologics for chronic immune-mediated conditions.
Patients’ Significance
Psoriasis and psoriatic arthritis in children can be physically debilitating and socially isolating, affecting school participation and self-esteem. TREMFYA®’s subcutaneous administration at Week 0, Week 4, and every 8 weeks thereafter provides a convenient and effective treatment option. Parents and care partners now have access to a therapy proven to improve skin clearance and reduce joint inflammation, offering children a chance to lead active, comfortable, and socially engaged lives. Experts emphasize that early intervention can significantly improve long-term outcomes for children living with these diseases.
Policy Significance
This FDA approval underscores the agency’s commitment to closing gaps in pediatric treatment for immune-mediated diseases. By accepting data extrapolation from adult trials to pediatric populations, the FDA demonstrates a progressive policy approach that enables earlier access to therapies for children. The decision also provides a regulatory model for future pediatric approvals, encouraging drug developers to pursue mechanism-based strategies and innovative trial designs to safely address rare pediatric diseases.
Transaction Highlights
The FDA approval of TREMFYA® (guselkumab) represents a significant advancement in pediatric immunology, establishing it as the first IL-23 inhibitor approved for children. The decision is based on robust data from the Phase 3 PROTOSTAR pediatric trial as well as supportive findings from adult studies, including VOYAGE 1 and 2 and DISCOVER 1 and 2. In pediatric patients with moderate to severe plaque psoriasis, 56% achieved PASI 90, 66% achieved high levels of skin clearance (IGA 0/1), and nearly 40% achieved complete clearance (IGA 0). TREMFYA® is administered as a subcutaneous injection at Week 0, Week 4, and then every 8 weeks, with a recommended dosage of 100 mg for pediatric patients weighing at least 40 kg. This approval not only sets a new benchmark in pediatric treatment for psoriasis and psoriatic arthritis but also strengthens Johnson & Johnson’s commercial position in IL-23 targeted therapies, providing an innovative, convenient, and effective option for children and their families.
Source: Johnson & Johnson Press Release
