Secukinumab (9) – Cosentyx®
Hidradenitis suppurativa (Acne inversa)
Characteristics
| Start date | 15.06.2023 – Marketing authorisation: 26.05.2023 |
|---|---|
| Resolution | 07.12.2023 |
| INN | Secukinumab |
| Brand name | Cosentyx® |
| Pharm. company | Novartis Pharma GmbH |
| G-BA Procedure ID | D-942 |
| ATC code | L04AC10 Interleukin inhibitors (L04AC) |
| ICD-10 codes (AIS) | L73.2Hidradenitis suppurativa |
| Alpha-ID codes (AIS) | I6373Hidradenitis suppurativa |
| Therapeutic area | Skin diseases Hidradenitis suppurativa (Acne inversa) |
| Reason for procedure | New therapeutic indication |
| Therapeutic indication of the resolution |
|---|
|
Cosentyx is indicated for the treatment of adult patients with moderate to severe active hidradenitis suppurativa (acne inversa) who have had an inadequate response to conventional systemic HS therapy. |
| Subpopulation | Indication | Comparator |
|---|---|---|
| Adults with moderate to severe active hidradenitis suppurativa (HS) who do not respond adequately to conventional systemic HS therapy | Adalimumab |
Studies and Results
|
No. of studies
(best subpopulation) |
2 (CAIN457M2301, CAIN457M2302) |
|---|---|
|
Study design
(best subpopulation) |
H2H vs. non-ACT + no ITC |
|
Meta analysis
(best subpopulation) |
no |
- Clinical trials
- In the dossier, the pharmaceutical manufacturer refers to the registration trials CAIN457M2301 and CAIN457M2302. These were double-blind, randomised, multicentre trials in which the efficacy of secukinumab compared with placebo was investigated in the above-mentioned patient population over a period of 16 weeks.
Adults with moderate to severe active hidradenitis suppurativa (HS) who have an inadequate response to conventional systemic HS therapy
- For adults with moderate to severe active hidradenitis suppurativa who have an inadequate response to conventional systemic HS therapy, the additional benefit of secukinumab compared with the appropriate comparator therapy is not proven.
- Overall, therefore, there are no data suitable for a benefit assessment that would allow a comparison of secukinumab with the appropriate comparator therapy. The additional benefit of secukinumab compared with the appropriate comparator therapy is therefore not proven.
- Overall assessment
- On balance, the additional benefit of secukinumab compared with the appropriate comparator therapy is not proven.
Courtesy translation only, please refer to the German original.
Associated procedures
<< List of all resolutions