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) |
| Therapeutic area | Skin diseases |
| Reason for procedure | Initial assessment |
| Regulatory status | Conditional Approval |
Studies and Results
- 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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