Johnson & Johnson — Tremfya EMA EPAR variation assessment report (EMEA/H/C/004271, 2017)
Johnson & Johnson · 2017 · EMA EPAR variation assessment report · company profile →
Report summary
The EMA assessed a variation for Tremfya (guselkumab) to include a new 45 mg/0.45 mL strength and an extended indication for moderate to severe plaque psoriasis in pediatric patients aged 6 and older. The CHMP issued a positive opinion, supported by similar disease pathobiology in adults and children. Manufacturing and quality control of the VarioJect device and drug product were confirmed, with a 24-month shelf life. Pharmacokinetic data showed comparable guselkumab serum concentrations across age and weight groups, with anti-drug antibodies not significantly impacting outcomes. Clinical study CNTO1959PSO3011 demonstrated guselkumab's superior efficacy over placebo in pediatric patients at Week 16 (IGA 0/1 and PASI 75). A weight-based dosing regimen was approved for patients under 40 kg, and a fixed 100 mg dose for those 40 kg and above. The safety profile in pediatric patients was consistent with adults, with no new concerns identified, though long-term pediatric safety data will be further monitored.
Key findings — cited to the page
| Participants with CTCAE toxicity Grade 2 decreased platelet count (placebo group) | 4 % | CNTO1959PSO3011 · p.85 |
| Participants with CTCAE toxicity Grade 2 decreased neutrophil count (etanercept group) | 4 % | CNTO1959PSO3011 · p.85 |
| Participants with CTCAE toxicity Grade 2 of increased total bilirubin (guselkumab group) | 7.3 % | CNTO1959PSO3011 · p.85 |
| Age range of participants | ≥6 to <18 years of age | Tremfya · p.98 |
| Trial phase | Phase 3 | Tremfya · p.98 |
| New strength of Tremfya | 45 mg/0.45 mL | Tremfya · p.6 |
| Co-primary endpoints in pediatric study CNTO1959PSO3011 | IGA 0/1 and PASI 75 at Week 16 | CNTO1959PSO3011 · p.10 |
| Extended indication for Tremfya | treatment of moderate to severe plaque psoriasis in children and adolescents from the age of 6 years who are candidates for systemic therapy | Tremfya · p.6 |
| CHMP positive opinion date | 16 October 2025 | Tremfya · p.7 |
| Study name | CNTO1959PSO3011 | Tremfya · p.98 |
| Phase of study CNTO1959PSO3011 | Phase 3 | CNTO1959PSO3011 · p.6 |
| PASI 75 response rate | 75.6 % | Tremfya · p.100 |
Source: Johnson & Johnson ↗ · License: EMA - reuse permitted with acknowledgement. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Immunology library →