Nemolizumab (1) – Nemluvio®
Atopic dermatitis, ≥ 12 years
Characteristics
| Start date | 15.02.2025 – Marketing authorisation: 12.02.2025 |
|---|---|
| Resolution | 07.08.2025 |
| INN | Nemolizumab |
| Brand name | Nemluvio® |
| Pharm. company | Galderma Laboratorium GmbH |
| G-BA Procedure ID | D-1171 |
| ATC code | D11AH12 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 |
| Specialty | Bundling |
| Therapeutic indication of the resolution |
|---|
|
Nemluvio is used for the treatment of moderate to severe atopic dermatitis in patients aged 12 years and older who are eligible for systemic therapy |
| Subpopulation | Indication | Comparator |
|---|---|---|
| Adults and adolescents aged 12 years and older 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 ARCADIA 1 and ARCADIA 2 trials, which formed the basis for marketing authorisation and were designed and conducted in a similar manner, a randomised comparison of nemolizumab versus placebo was carried out 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.
- Overall, therefore, for adults and adolescents aged 12 years and over with moderate to severe atopic dermatitis who are eligible for systemic therapy, the additional benefit of nemolizumab over the appropriate comparator therapy is not proven.
Courtesy translation only, please refer to the German original.
Associated procedures
| Nemolizumab (1) | Nemluvio® | Galderma Laboratorium GmbH | Atopic dermatitis, ≥ 12 years | 57,300–62,600 | 100% additional benefit not proven | |
| Nemolizumab (2) | Nemluvio® | Galderma Laboratorium GmbH | Prurigo nodularis | 3,500–5,500 | 100% additional benefit not proven |
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