Voclosporin (1) – Lupkynis®

• 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.