Sanofi — Dupixent EMA EPAR public assessment report (EMEA/H/C/004390, 2017)
Sanofi · 2017 · EMA EPAR public assessment report · company profile →
Report summary
The EMA's 2017 assessment of Dupixent (dupilumab) for moderate-to-severe adult atopic dermatitis led to a positive marketing authorization. The report details its pharmaceutical development, confirming stability and its IL-4Rα inhibitor mechanism. Pharmacokinetic studies showed nonlinear clearance and body weight influence. Clinical trials (SOLO 1, SOLO 2, CHRONOS, CAFE) consistently demonstrated significant efficacy, improving IGA 0/1, EASI-75, and pruritus scores, both as monotherapy and with topical corticosteroids. Safety data indicated a favorable profile with lower serious adverse events than placebo, though injection site reactions and conjunctivitis were more common. The CHMP concluded a positive benefit-risk balance, supporting its approval.
Key findings — cited to the page
| Number of patients in dupilumab 300 mg Q2W + TCS group | 106 | R668-AD-1224 · p.36 |
| Proportion of patients with IGA 0 or 1 and reduction of ≥ 2 points at week 16 | 39.2 % | R668-AD-1224 · p.38 |
| Randomization ratio (dupilumab 300 mg QW : dupilumab 300 mg Q2W : placebo) | 3:1:3 | R668-AD-1224 · p.34 |
| Number of patients in placebo + TCS group | 315 | R668-AD-1224 · p.36 |
| Number of patients in dupilumab 300 mg QW + TCS group | 319 | R668-AD-1224 · p.36 |
| Proportion of patients with IGA 0 or 1 and reduction of ≥ 2 points at week 16 | 38.7 % | R668-AD-1224 · p.38 |
| Withdrawal due to AEs (all patients) | 3.3 % | R668-AD-1334 (Solo1) · p.46 |
| Number of patients planned to be enrolled | 700 | R668-AD-1224 · p.34 |
| Number of patients screened | 957 | R668-AD-1224 · p.36 |
| Number of patients enrolled and randomized | 740 | R668-AD-1224 · p.36 |
| Application submission date | 4 November 2016 | Dupixent · EU · p.7 |
| Proportion of patients with IGA 0 or 1 and reduction of ≥ 2 points at week 16 | 12.4 % | R668-AD-1224 · p.38 |
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 →