Sanofi — Dupixent EMA EPAR variation assessment report (EMEA/H/C/004390, 2017)
Sanofi · 2017 · EMA EPAR variation assessment report · company profile →
Report summary
This report details a Type II variation application for Dupixent (dupilumab) to extend its indication to moderate to severe chronic spontaneous urticaria (CSU) in children aged 2 to 11 years. The application relies on pharmacokinetic (PK) and safety data from study PKM16982, combined with an extrapolation approach from existing adult/adolescent CSU data and pediatric data from other indications (AD, asthma, EoE). A global pediatric population PK model was developed to predict steady-state exposure across weight-tiered dosing regimens. While pediatric efficacy data from PKM16982 and EFC16461 were limited and uncontrolled, showing some improvements in scores, the overall efficacy claim is primarily based on extrapolation and exposure matching. The safety profile in this pediatric population was favorable, with no new concerns identified. The benefit-risk balance is considered positive, leading to the approval of this indication extension.
Key findings — cited to the page
| Type II variation application submission date | 30 June 2025 | · p.5 |
| CHMP Opinion date | 26 February 2026 | · p.6 |
| Number of participants enrolled/treated in study PKM16982 | 15 | PKM16982 (CUPIDKids) · p.11 |
| Number of participants randomized/treated in study EFC16461 Study A | 138 | EFC16461 (CUPID) Study A · p.11 |
| Number of children (≥6 to <12 years) in dupilumab arm in study EFC16461 Study A | 2 | EFC16461 (CUPID) Study A · p.11 |
| Number of PK concentrations in final pooled paediatric dataset | 3748 | · p.14 |
| Number of paediatric patients in final pooled dataset | 1019 | · p.14 |
| Number of children with AD in final pooled dataset | 544 | · p.14 |
| Number of children with asthma in final pooled dataset | 377 | · p.14 |
| Number of children with EoE in final pooled dataset | 98 | · p.14 |
| Number of paediatric AD patients aged ≥6 to <12 years in R668-AD-1412 | 37 | R668-AD-1412 · p.14 |
| Number of paediatric AD patients aged ≥6 months to <6 years in R668-AD-1539 | 188 | R668-AD-1539 · p.14 |
Source: Sanofi ↗ · 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 →