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) |
| Therapeutic area | Skin diseases |
| Reason for procedure | Initial assessment |
| Specialty | Bundling |
Studies and Results
- 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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