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Aurinia Announces Positive Topline Results From the AURORA 2 Continuation Study of LUPKYNIS™ (voclosporin) for the Treatment of Adults With Active Lupus Nephritis (LN)
- Study demonstrated a favorable risk/benefit profile over a three-year period, with safety comparable to AURORA 1, and sustained efficacy - - Topline
About this update from Aurinia Pharmaceuticals Inc
[{"type":"text","content":"\n- Study demonstrated a favorable risk/benefit profile over a three-year period, with safety comparable to AURORA 1, and sustained efficacy -\n\n- Topline results show sustained meaningful reductions in proteinuria compared to mycophenolate mofetil (MMF) and low-dose oral corticosteroids alone, the active study control -\n\n- Similar to the active control, the voclosporin-treated group maintained stable renal function at the end of the study -\n\n- Aurinia to host conference call today, December 9, at 8:30 a.m. EST -\n\n VICTORIA, British Columbia--(BUSINESS WIRE)--\nAurinia Pharmaceuticals Inc. (NASDAQ:AUPH) (Aurinia or the Company), a biopharmaceutical company committed to delivering therapeutics that change the course of autoimmune disease, today announced positive topline results from the AURORA 2 continuation study evaluating the long-term safety and tolerability of LUPKYNIS™ (voclosporin) for the treatment of adults with active lupus nephritis (LN), a serious complication in patients with systemic lupus erythematosus (SLE). In combination with background immunosuppressive therapy, LUPKYNIS is the first and only FDA-approved medicine with three years of pivotal trial results, including long-term safety data, within LN.\n\n“Up to half of patients with systemic lupus erythematosus will develop lupus nephritis, that can result in severe and permanent damage to the kidneys and, in some cases, renal failure,” said Amit Saxena, M.D., assistant professor, department of medicine at NYU Langone Medical Center and an investigator in the AURORA 2 study. “These highly anticipated long-term results, of voclosporin in adult patients with LN, show consistent safety with the phase 3 AURORA 1 study and a benign impact on eGFR even after up to three years of treatment while maintaining the impressive reductions in proteinuria seen in AURORA 1.”\n\n“We are pleased by the final results of the AURORA 2 continuation study evaluating LUPKYNIS for the treatment of lupus nephritis, which supports the long-term safety and tolerability for up to three years,” said Neil Solomons, M.D., Chief Medical Officer of Aurinia. “Furthermore, we observed that efficacy was maintained in combination with MMF and low-dose steroids.”\n\nHighlights of topline results from AURORA 2:\n\n\nIn the 116 subjects in the voclosporin-treated group who enrolled in AURORA 2, ...