Nemolizumab (2) – Nemluvio®
Prurigo nodularis
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-1172 |
| ATC code | D11AH12 Agents for dermatitis, excluding corticosteroids (D11AH) |
| ICD-10 codes (AIS) | L28.1Prurigo nodularis |
| Alpha-ID codes (AIS) | I6091Prurigo nodularis |
| Therapeutic area | Skin diseases Pruitus / Prurigo nodularis |
| Reason for procedure | Initial assessment |
| Specialty | Bundling ACT change |
| Therapeutic indication of the resolution |
|---|
|
Nemluvio is used for the treatment of adults with moderate to severe prurigo nodularis who are eligible for systemic therapy. |
| Subpopulation | Indication | Comparator |
|---|---|---|
| Nemluvio is used for the treatment of adults with moderate to severe prurigo nodularis who are eligible for systemic therapy | Dupilumab |
Studies and Results
|
No. of studies
(best subpopulation) |
1 (OLYMPIA 1) 0 (Data not accepted) |
|---|---|
|
Study design
(best subpopulation) |
Data not accepted (Dossier: H2H vs. non-ACT + no ITC) |
| ACT change | 15.01.2025 – Stellungnahme der Fachgesellschaften |
- Clinical trials
- In the dossier, the pharmaceutical manufacturer presents the data from the 24-week, double-blind, randomised OLYMPIA 1 trial comparing nemolizumab with placebo.
Adults with moderate to severe prurigo nodularis who are eligible for systemic therapy
- For adults with moderate to severe prurigo nodularis who are eligible for systemic therapy, the additional benefit is not proven.
- No direct comparative data are available for nemolizumab versus the appropriate comparator therapy, dupilumab.
- Overall, therefore, for adults with moderate to severe prurigo nodularis 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 |
<< List of all resolutions