Tralokinumab (1) – Adtralza®
Atopic dermatitis (AD)
Characteristics
| Start date | 15.07.2021 – Marketing authorisation: 17.06.2021 |
|---|---|
| Resolution | 06.01.2022 |
| INN | Tralokinumab |
| Brand name | Adtralza® |
| Pharm. company | Leo Pharma A/S |
| G-BA Procedure ID | D-710 |
| ATC code | D11AH07 Agents for dermatitis, excluding corticosteroids (D11AH) |
| DDD | 16.1 mg P |
| Therapeutic area | Skin diseases |
| Reason for procedure | Initial assessment |
Studies and Results
- Clinical trials
- In both studies, placebo was used as the comparator treatment.
- The ECZTRA 3 and ECZTRA 7 studies are randomised, double-blind trials investigating treatment with tralokinumab in adult patients with moderate to severe atopic dermatitis who are eligible for systemic therapy.
Adults with moderate to severe atopic dermatitis who are eligible for continuous systemic therapy
- For adult patients with moderate to severe atopic dermatitis who are eligible for continuous systemic therapy, the additional benefit of tralokinumab compared with the appropriate comparator therapy is not proven.
- No suitable data are available for assessing the additional benefit of tralokinumab compared with the appropriate comparator therapy in adult patients with moderate to severe atopic dermatitis who are eligible for systemic therapy. Consequently, there is no hint that tralokinumab offers any additional benefit over the appropriate comparator therapy; an additional benefit is therefore not proven.
Courtesy translation only, please refer to the German original.
Associated procedures
| Tralokinumab (2) | Adtralza® | LEO Pharma GmbH | Atopic dermatitis (AD), 12 to < 18 years | 5,300–10,600 | 100% additional benefit not proven | |
| Tralokinumab (1) | Adtralza® | Leo Pharma A/S | Atopic dermatitis (AD) | 52,000 | 100% additional benefit not proven |
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