Tralokinumab (2) – Adtralza®
Atopic dermatitis (AD), 12 to < 18 years
Characteristics
| Start date | 15.11.2022 – Marketing authorisation: 14.10.2022 |
|---|---|
| Resolution | 12.05.2023 |
| INN | Tralokinumab |
| Brand name | Adtralza® |
| Pharm. company | LEO Pharma GmbH |
| G-BA Procedure ID | D-888 |
| ATC code | D11AH07 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 |
| DDD | 16.1 mg P |
| Therapeutic area | Skin diseases Atopic dermatitis (AD) |
| Reason for procedure | New therapeutic indication |
| Therapeutic indication of the resolution |
|---|
|
Adtralza is used for the treatment of moderate to severe atopic dermatitis in adolescents aged 12 years and older who are eligible for systemic therapy. |
| Subpopulation | Indication | Comparator |
|---|---|---|
| Adolescents 12 to 17 years of age with moderate to severe atopic dermatitis who are eligible for continuous systemic therapy | Dupilumab (possibly in combination with topical glucocorticoids (TCS) and/or topical calcineurin inhibitors (TCI)) |
Studies and Results
|
No. of studies
(best subpopulation) |
0 (no data submitted) |
|---|---|
|
Study design
(best subpopulation) |
no data submitted (Dossier: H2H vs. non-ACT + no ITC) |
- Clinical trials
- The ECZTRA 6 trial compares two different doses of tralokinumab with placebo in adolescents aged 12 years and over with moderate to severe atopic dermatitis.
Young people aged 12 to 17 with moderate to severe atopic dermatitis who are eligible for continuous systemic therapy
- No relevant study was identified for the assessment of the additional benefit of tralokinumab compared with the appropriate comparator therapy.
- There are therefore no suitable data available for assessing the additional benefit of tralokinumab compared with the appropriate comparator therapy in adolescents aged 12 years and over with moderate to severe atopic dermatitis who are eligible for continuous 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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