Spesolimab (1) – Spevigo®
Generalised pustular psoriasis, acute treatment
Characteristics
| Start date | 01.02.2023 – Marketing authorisation: 09.12.2022 |
|---|---|
| Resolution | 20.07.2023 |
| INN | Spesolimab |
| Brand name | Spevigo® |
| Pharm. company | Boehringer Ingelheim Pharma GmbH & Co. KG |
| G-BA Procedure ID | D-902 |
| ATC code | L04AC22 Interleukin inhibitors (L04AC) |
| ICD-10 codes (AIS) | L40.1Impetigo herpetiformis |
| Alpha-ID codes (AIS) | I119825Generalized pustular psoriasis |
| Therapeutic area | Skin diseases Plaque psoriasis (PP) |
| Reason for procedure | Initial assessment |
| Regulatory status | Conditional Approval |
| Therapeutic indication of the resolution |
|---|
|
Spevigo is used to treat relapses in adult patients with generalized pustular psoriasis (GPP) as monotherapy. |
| Subpopulation | Indication | Comparator |
|---|---|---|
| Adults with generalized pustular psoriasis with an acute episode | Therapy as prescribed by a physician, taking into account systemic glucocorticoids and best-supportive care |
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
- The EFFISAYIL 1 trial was a double-blind, randomised, multicentre trial comparing spesolimab with placebo.
Adults with generalised pustular psoriasis experiencing an acute flare-up
- For adult patients experiencing an acute flare-up of generalised pustular psoriasis, the additional benefit is not proven.
- In summary, due to the short study duration of 8 days in this case and the inadequate treatment for flare-up control, the EFFISAYIL 1 study is not suitable for to draw any conclusions regarding the additional benefit of spesolimab for the treatment of flare-ups in adult patients with generalised pustular psoriasis.
Courtesy translation only, please refer to the German original.
Associated procedures
| Spesolimab (1) | Spevigo® | Boehringer Ingelheim Pharma GmbH & Co. KG | Generalised pustular psoriasis, acute treatment | 170–400 | 100% additional benefit not proven |
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