By Fineline Cube 
Johnson & Johnson (J&J, NYSE: JNJ) announced that the European Commission (EC) has extended the marketing authorization for TREMFYA (guselkumab) as a subcutaneous treatment for moderate to severe plaque psoriasis in children and adolescents from age 6 years, making it the first IL‑23 inhibitor approved for any pediatric indication.
Regulatory Milestone & Indication
| Attribute | Details |
|---|---|
| Company | Johnson & Johnson (NYSE: JNJ) |
| Product | TREMFYA (guselkumab) |
| Regulatory Authority | European Commission (EC) |
| Approval Type | Marketing authorization extension |
| Indication | Moderate to severe plaque psoriasis (Pso) in pediatric patients (≥6 years) |
| Significance | First IL‑23 inhibitor approved for pediatric use globally |
Clinical Basis: Phase 3 PROTOSTAR & VOYAGE Studies
| Study | Design | Patient Population | Key Results at Week 16 |
|---|---|---|---|
| PROTOSTAR | Phase 3, randomized, placebo‑controlled | 120 pediatric patients (6‑17 years) | PASI 75: 76% vs. 20% placebo (p<0.001) IGA 0/1: 66% vs. 16% placebo (p<0.001) |
| VOYAGE 1 & 2 | Phase 3 (bridging PK data) | Adult patients with moderate to severe plaque Pso | Established pharmacokinetic and safety profile for guselkumab |
Safety & Efficacy Highlights
- Primary Endpoints: Both PASI 75 and IGA 0/1 achieved at Week 16 in PROTOSTAR
- Response Rates: Significantly superior to placebo (p<0.001 for both endpoints)
- Safety Profile: Consistent with adult population; no new safety signals in pediatric patients
- Dosing: Subcutaneous injection regimen identical to adult dosing
Market Context & Strategic Outlook
- Psoriasis Burden: 1.5 million pediatric patients globally affected by moderate to severe plaque psoriasis
- Unmet Need: Limited biologic options for children; topical therapies often insufficient
- Competitive Landscape: TREMFYA is first IL‑23 inhibitor in pediatric space; competes with TNF inhibitors and IL‑17 inhibitors in adult market
- Revenue Impact: Analysts estimate $500‑700 million in additional peak sales from pediatric indication
- Launch Timeline: European rollout expected Q2 2026 following pricing and reimbursement discussions
Forward‑Looking Statements
This brief contains forward‑looking statements regarding TREMFYA’s pediatric commercialization timelines, market penetration, and safety profile. Actual results may differ due to regulatory, competitive, and market access uncertainties.-Fineline Info & Tech