Almirall S A — Ebglyss EMA EPAR public assessment report (EMEA/H/C/005894, 2023)
Almirall S A · 2023 · EMA EPAR public assessment report
Report summary
This report summarizes the marketing authorization application for Ebglyss (lebrikizumab) by Almirall, S.A. for moderate-to-severe atopic dermatitis. It details the product's manufacturing, quality control, and stability, along with non-clinical toxicology and pharmacokinetic studies, primarily in cynomolgus monkeys, showing good tolerability. Clinical pharmacology, including PK/PD properties and bioanalytical methods, is discussed, noting no significant impact of demographics on exposure. Pivotal Phase 3 trials (KGAB, KGAC, KGAD) demonstrated lebrikizumab's significant efficacy in improving IGA 0/1, EASI-75/90, and pruritus in both induction and maintenance phases, as monotherapy and with topical corticosteroids, across adult and adolescent populations. The safety profile, evaluated across various periods, identified common adverse events like conjunctivitis and nasopharyngitis, with no major safety concerns. Immunogenicity and safety in special populations were also addressed, concluding a manageable safety profile.
Key findings — cited to the page
| Lebrikizumab concentration | 125 mg/mL | Ebglyss · p.12 |
| Lebrikizumab heavy chain amino acid residues | 445 | Lebrikizumab · p.12 |
| Legal basis for application | Article 8.3 of Directive 2001/83/EC | · p.7 |
| CHMP positive opinion date | 14 September 2023 | Ebglyss · p.9 |
| Paediatric Investigation Plan (PIP) decision number | P/0286/2021 | · p.7 |
| Proposed indication | treatment of moderate-to-severe atopic dermatitis in adults and adolescents 12 years of age and older who are candidates for systemic therapy | Ebglyss · p.7 |
| New active substance status requested | true | Lebrikizumab · EU · p.7 |
| Dupilumab approval year | 2017 | Dupilumab · p.11 |
| Tralokinumab approval year | 2021 | Tralokinumab · p.11 |
| Proposed initial dose of lebrikizumab | 500 mg | Lebrikizumab · p.11 |
| Proposed maintenance dose of lebrikizumab | 250 mg | Lebrikizumab · p.11 |
| Lebrikizumab light chain amino acid residues | 218 | Lebrikizumab · p.12 |
Source: Almirall S A ↗ · 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 →