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Aurinia Presents Voclosporin Efficacy and Pharmacokinetic Data from Integrated Analysis of AURA-LV and AURORA Pivotal Trials at ASN Kidney Week 2020
- Integrated analysis confirms statistically superior efficacy and safety of voclosporin in combination with MMF and steroids over standard-of-care – -
About this update from Aurinia Pharmaceuticals Inc
[{"type":"text","content":"\n- Integrated analysis confirms statistically superior efficacy and safety of voclosporin in combination with MMF and steroids over standard-of-care –\n\n- Voclosporin pharmacokinetic data supports consistent dose-response, potentially eliminating the need for therapeutic drug monitoring –\n\n VICTORIA, British Columbia--(BUSINESS WIRE)--\nAurinia Pharmaceuticals Inc. (Nasdaq:AUPH / TSX:AUP) (“Aurinia” or the “Company”), a late-stage clinical biopharmaceutical company focused on advancing voclosporin across multiple indications, today announced that integrated efficacy and pharmacokinetic (PK) data from Aurinia’s AURA-LV and AURORA pivotal trials of voclosporin in lupus nephritis (LN) were presented. The data were shared at the American Society of Nephrology (ASN) Kidney Week 2020 in presentations given by Brad Rovin, M.D., FASN, Director of Nephrology and Vice Chairman of Research for the Department of Internal Medicine at the Ohio State University Wexner Medical Center and Teun van Gelder, Professor in Clinical Pharmacology for the Department of Clinical Pharmacy and Toxicology at the Leiden University Medical Center.\n\n“People living with lupus nephritis are in a race against time to get their disease under control with the goal of improving their long term kidney health. We are pleased that the pooled analysis from our AURA-LV and AURORA pivotal trials further underscores voclosporin’s potential as an important tool to help people quickly change the course of their disease,” said Neil Solomons, M.D., Chief Medical Officer of Aurinia. “Together with the supportive pharmacokinetic data, these findings add to the growing body of information available on voclosporin as an investigational drug that could provide an important treatment approach for people dealing with LN.”\n\nData from a total of 534 patients from AURA-LV and AURORA was integrated and presented, demonstrating that 268 patients with LN treated with voclosporin in combination with mycophenolate mofetil (MMF) and low-dose steroids achieved statistically superior and faster Renal Response rates compared to 266 patients treated with MMF and steroids alone. The effects were also observed in Hispanic patients, a high-risk lupus nephritis population. Treatment with voclosporin resulted in clinically meaningful and a statistically significant higher Renal Response rate o...