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Aurinia Presents Data Demonstrating LUPKYNIS™ (voclosporin) Efficacy Across Lupus Nephritis Biopsy Classes at National Kidney Foundation 2021 Spring Clinical Meetings
Additional efficacy data from pooled analysis of AURA-LV and AURORA 1 pivotal trials demonstrate potential to improve renal response regardless of disease
About this update from Aurinia Pharmaceuticals Inc
[{"type":"text","content":"\nAdditional efficacy data from pooled analysis of AURA-LV and AURORA 1 pivotal trials demonstrate potential to improve renal response regardless of disease progression at diagnosis \n\n VICTORIA, British Columbia & ROCKVILLE, Md.--(BUSINESS WIRE)--\nAurinia Pharmaceuticals Inc. (NASDAQ: AUPH / TSX: AUP) (Aurinia or the Company) today presented additional efficacy data from the AURA-LV and AURORA 1 pivotal trials of LUPKYNIS™ (voclosporin) in lupus nephritis (LN). The data were shared at the National Kidney Foundation (NKF) 2021 Spring Clinical Meetings by Anca D. Askanase, M.D., M.P.H., Founder and Director of Columbia University Irving Medical Center’s Lupus Center and the Director of Rheumatology Clinical Trials.\n\nPooled data from the AURA-LV and AURORA 1 study demonstrate that LUPKYNIS, in combination with mycophenolate mofetil (MMF) and low-dose corticosteroids, led to treatment benefits across biopsy class subgroups compared with treatment with MMF and low-dose corticosteroids alone (placebo). MMF and low-dose corticosteroids are considered standard of care (SoC) for the treatment of LN. On January 22, 2021, the U.S. Food and Drug Administration (FDA) approved LUPKYNIS in combination with a background immunosuppressive therapy regimen to treat adult patients with active LN.\n\n“People with LN can sometimes have a delay in diagnosis and often incomplete responses to treatment, increasing their likelihood of kidney damage and other disease complications. These data support LUPKYNIS’ potential as an important tool to control LN regardless of the disease classification,” said Anca D. Askanase, M.D., MPH, Founder and Director of Columbia University Irving Medical Center’s Lupus Center and the Director of Rheumatology Clinical Trials.\n\nData from 532 patients from the AURA-LV and AURORA 1 studies were integrated in a post-hoc analysis of complete renal response (CRR) by LN biopsy class. The AURA-LV and AURORA 1 studies were similar in design and patient populations. The data from both studies for subjects treated with the recommended LUPKYNIS dose of 23.7 mg twice daily (AURA-LV n=89, AURORA 1 n=179) or with matching placebo (AURA-LV n=88, AURORA 1 n= 178) were pooled for the integrated analysis. The odds ratios (OR) for CRR for LUPKYNIS versus placebo were 4.26 for pure Class III (p=0.0054), 2.59 for pure Class IV (p=0.0005)...