Voclosporin (1) – Lupkynis®
Lupusnephritis
Characteristics
| Start date | 01.03.2023 – Marketing authorisation: 15.09.2022 |
|---|---|
| Resolution | 17.08.2023 |
| INN | Voclosporin |
| Brand name | Lupkynis® |
| Pharm. company | Otsuka Pharma GmbH |
| G-BA Procedure ID | D-914 |
| ATC code | L04AD03 Calcineurin inhibitors (L04AD) |
| ICD-10 codes (AIS) | M32.1Systemic lupus erythematosus with organ or system involvement |
| Alpha-ID codes (AIS) | I24394Visceral lupus erythematosus |
| Therapeutic area | Musculoskeletal system diseases Lupusnephritis |
| Reason for procedure | Initial assessment |
| Therapeutic indication of the resolution |
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|
Lupkynis is used in combination with mycophenolate mofetil (MMF) for the treatment of adult patients with Class III, IV, or V (including mixed Class III/V and IV/V) active lupus nephritis (LN). |
| Subpopulation | Indication | Comparator |
|---|---|---|
| Adults with active class III, IV, or V lupus nephritis (including mixed classes III/V and IV/V), in combination with mycophenolate mofetil | Patient-specific therapy, taking into account previous therapy and disease activity, if any, and selecting the following agents: glucocorticoids, azathioprine, cyclophosphamide, hydroxychloroquine, chloroquine, mycophenolate mofetil/mycophenolenic acid |
Studies and Results
|
No. of studies
(best subpopulation) |
0 (Data not accepted) |
|---|---|
|
Study design
(best subpopulation) |
Data not accepted (Dossier: H2H vs. non-ACT + ITC (MTC)) |
- Clinical trials
- The AURA-LV trial was a randomised, controlled, double-blind Phase 2 trial in which a total of 265 patients aged between 18 and 75 years with active lupus nephritis of classes III, IV and V (including mixed classes III/V and IV/V).
- The AURORA-1 trial is a randomised, controlled, double-blind Phase 3 trial comparing voclosporin with placebo, which enrolled a total of 357 patients aged between 18 and 75 years with active lupus nephritis of classes III, IV and V (including mixed Class III/V and IV/V) and a diagnosis of SLE (in accordance with the 1997 ACR criteria).
- Of the 357 patients randomised in the AURORA-1 study, 216 took part in the AURORA-2 extension study.
Adults with active lupus nephritis of class III, IV or V (including mixed classes III/V and IV/V), in combination with mycophenolate mofetil
- For adults with active lupus nephritis of class III, IV or V (including mixed classes III/V and IV/V), in combination with mycophenolate mofetil, additional benefit is not proven.
- In summary, no suitable data were submitted for the assessment of the additional benefit of voclosporin compared with the appropriate comparator therapy determined by the G-BA, namely a patient-specific treatment taking into account, where applicable, prior therapy and disease activity, with a choice of glucocorticoids, azathioprine, cyclophosphamide, hydroxychloroquine, chloroquine and mycophenolate mofetil. Accordingly, the additional benefit is not proven.
Courtesy translation only, please refer to the German original.
Associated procedures
| Voclosporin (1) | Lupkynis® | Otsuka Pharma GmbH | Lupusnephritis | 1,090–13,050 | 100% additional benefit not proven |
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