Lebrikizumab (1) – Ebglyss®
Atopic dermatitis, ≥ 12 years
Characteristics
| Start date | 15.12.2023 – Marketing authorisation: 16.11.2023 |
|---|---|
| Resolution | 06.06.2024 |
| INN | Lebrikizumab |
| Brand name | Ebglyss® |
| Pharm. company | Almirall Hermal GmbH |
| G-BA Procedure ID | D-994 |
| ATC code | D11AH10 Agents for dermatitis, excluding corticosteroids (D11AH) |
| ICD-10 codes (AIS) | L20.0Besnier´s prurigo, L20.8Other atopic dermatitis, L20.9Atopic dermatitis, unspecified |
| Alpha-ID codes (AIS) | I19541Neurodermatitis, I28531Prurigo Besnier, I9918Atopic dermatitis |
| Therapeutic area | Skin diseases Atopic dermatitis (AD) |
| Reason for procedure | Initial assessment |
| Therapeutic indication of the resolution |
|---|
|
Ebglyss is used for the treatment of moderate to severe atopic dermatitis in adults and adolescents aged 12 years and over with a body weight of at least 40 kg who are eligible for systemic therapy. |
| Subpopulation | Indication | Comparator |
|---|---|---|
| Adults and adolescents aged 12 years and over with moderate to severe atopic dermatitis who are eligible for systemic therapy | Dupilumab (possibly in combination with TCS and/or TCI) |
Studies and Results
|
No. of studies
(best subpopulation) |
0 (Data not accepted) |
|---|---|
|
Study design
(best subpopulation) |
Data not accepted (Dossier: H2H vs. non-ACT + no ITC) |
- Clinical trials
- In the pivotal trials ADvocate, Advocate 2 and ADhere, a randomised comparison with placebo was conducted over 16 weeks.
Adults and adolescents aged 12 years and over with moderate to severe atopic dermatitis who are eligible for systemic therapy
- For adults and adolescents aged 12 years and over with moderate to severe atopic dermatitis who are eligible for systemic therapy, the additional benefit is not proven.
- An additional benefit is therefore not proven.
- No relevant study was identified for the assessment of the additional benefit of lebrikizumab compared with the appropriate comparator therapy.
- In accordance with the pharmaceutical manufacturer’s approach as set out in the dossier, these studies are not taken into account for the present benefit assessment, as no conclusions regarding the additional benefit of lebrikizumab compared with the appropriate comparator therapy can be drawn from them.
- There are therefore no suitable data available for assessing the additional benefit of lebrikizumab compared with the appropriate comparator therapy in adults and adolescents aged 12 years and over with moderate to severe atopic dermatitis for whom systemic therapy is an option.
- Consequently, there is no hint that lebrikizumab offers any additional benefit compared with the appropriate comparator therapy.
Courtesy translation only, please refer to the German original.
Associated procedures
| Lebrikizumab (1) | Ebglyss® | Almirall Hermal GmbH | Atopic dermatitis, ≥ 12 years | 57,300–62,600 | 100% additional benefit not proven |
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