• 30 Sep 2025
• Admin
• News Article

Johnson & Johnson Receives FDA Approval for TREMFYA® in Pediatric Psoriasis and Psoriatic Arthritis

Johnson & Johnson (NYSE: JNJ) today announced that the U.S. Food and Drug Administration (FDA) has approved TREMFYA® (guselkumab) for children aged six years and older who weigh at least 40 kg with:

• Moderate to severe plaque psoriasis (PsO) who are candidates for systemic therapy or phototherapy
• Active psoriatic arthritis (PsA)

This approval makes TREMFYA® the first and only IL-23 inhibitor approved for these pediatric indications, building on prior adult approvals for moderate to severe plaque PsO (2017) and active PsA (2020).

Patient Impact

• About 20,000 children under 10 are diagnosed with plaque PsO annually in the U.S.
• Approximately 14,000 children are affected by PsA.
• PsO and PsA in children can be painful, itchy, and emotionally challenging, impacting daily activities, school, and social life.

Clinical Evidence

• Approval for pediatric PsO is based on the Phase 3 PROTOSTAR study in children and supportive adult data from VOYAGE 1 and 2.
  - PASI 90 (skin clearance) at Week 16: 56% on TREMFYA® vs. 16% placebo
  - IGA 0/1 (clear or almost clear skin) at Week 16: 66% on TREMFYA® vs. 16% placebo
  - Nearly 40% of children achieved complete clearance (IGA 0) vs. 4% placebo
• PsA approval was supported by pharmacokinetic extrapolation analyses from pediatric PsO and adult PsO/PsA studies.

Administration

• Subcutaneous injection at Week 0, Week 4, and then every 8 weeks
• Recommended dose: 100 mg via 1 mL prefilled syringe

Expert Perspective

• Dr. Vimal Prajapati, University of Calgary: "TREMFYA offers physicians, parents, and care partners an established treatment option with proven safety and demonstrated efficacy that can significantly improve the signs and symptoms in children."
• Leah M. Howard, JD, National Psoriasis Foundation: "The National Psoriasis Foundation welcomes any new treatment option that provides hope for relief from the pain, discomfort, and emotional burden of these conditions."

About TREMFYA®

TREMFYA® is a fully-human, dual-acting monoclonal antibody that blocks IL-23 and binds to CD64 on cells producing IL-23, targeting inflammation at the cellular source. It is also approved for:

• Adults with moderate to severe plaque PsO
• Adults with active PsA
• Adults with moderately to severely active ulcerative colitis or Crohn’s disease

Safety Information

TREMFYA® may cause serious allergic reactions, infections, and liver problems. Patients should discuss all medical conditions, medications, and vaccinations with their healthcare provider before starting treatment. Common side effects include respiratory infections, headache, injection site reactions, joint pain, diarrhea, and fatigue.

About Johnson & Johnson

Johnson & Johnson is a global healthcare leader dedicated to preventing, treating, and curing complex diseases through innovation in pharmaceuticals, MedTech, and consumer health.