Galderma — Nemluvio EMA EPAR variation assessment report (EMEA/H/C/006149, 2025)
Galderma · 2025 · EMA EPAR variation assessment report
Report summary
This report summarizes the assessment of a pediatric study (RD.06.SPR.118126) for Nemluvio (nemolizumab) in children aged 2-11 with moderate-to-severe atopic dermatitis. The study evaluated pharmacokinetics, safety, and efficacy over 52 weeks. Clinically meaningful improvements were observed in EASI, IGA, and pruritus scores. Initial dosing in Cohort 1 led to higher systemic exposure than adults, but adjusted dosing in Cohorts 1.1 and 2 achieved comparable exposure. No new safety signals were identified.
Key findings — cited to the page
| Number of subjects enrolled and received at least 1 dose in study RD.06.SPR.118126 | 109 subjects | RD.06.SPR.118126 · p.6 |
| EASI-75 response rate | 45.0 % | RD.06.SPR.118126 · p.9 |
| EASI-75 response rate | 88.0 % | RD.06.SPR.118126 · p.9 |
| EASI-75 response rate in Cohort 1 | 27.8 % | RD.06.SPR.118126 · p.9 |
| EASI-75 response rate in Cohort 1 | 93.8 % | RD.06.SPR.118126 · p.9 |
| EASI-75 response rate in Cohort 1.1 | 82.9 % | RD.06.SPR.118126 · p.9 |
| EASI-75 response rate in Cohort 2 | 58.3 % | RD.06.SPR.118126 · p.9 |
| EASI-75 response rate in Cohort 2 | 87.9 % | RD.06.SPR.118126 · p.9 |
| EASI-90 response rate | 23.9 % | RD.06.SPR.118126 · p.10 |
| EASI-90 response rate | 67.0 % | RD.06.SPR.118126 · p.10 |
| EASI-90 response rate in Cohort 1 | 8.3 % | RD.06.SPR.118126 · p.10 |
| Number of subjects screened in study RD.06.SPR.118126 | 126 subjects | RD.06.SPR.118126 · p.6 |
Source: Galderma ↗ · 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 →