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     232  0 Kommentare Aurinia Announces Publication of AURORA 1 Phase 3 Study Results with LUPKYNIS (voclosporin) in The Lancet

    Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH / TSX: AUP) (“Aurinia” or the “Company”) today announced that The Lancet, an international, peer-reviewed medical journal, published the results of the Company’s Phase 3 AURORA 1 study evaluating LUPKYNIS (voclosporin) in adults with lupus nephritis (LN). The AURORA 1 study results demonstrate that LUPKYNIS in combination with mycophenolate mofetil (MMF) and low-dose corticosteroids led to statistically superior complete renal response rates at 52 weeks compared to treatment with MMF and low-dose corticosteroids alone, with a comparable safety profile. In fact, separation in efficacy between treatment groups was observed as early as 4 weeks. MMF and corticosteroids are typical SoC immunosuppressive agents used 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.

    “Lupus nephritis can be a devastating condition if not diagnosed and managed early,” stated Brad H. Rovin, M.D., Professor of Medicine and the Director of the Division of Nephrology, Ohio State University Wexler Medical Center, an AURORA clinical trial investigator and the lead author of the publication. “The publication of AURORA 1 data validates the importance of voclosporin (LUPKYNIS) in early disease intervention for LN. These data establish voclosporin as an efficacious and safe, rapid-acting new treatment option for patients in need.”

    The published AURORA 1 results are based on the global Phase 3 randomized, double-blind, placebo-controlled study (NCT03021499) designed to evaluate the efficacy and safety of LUPKYNIS (23.7 mg twice daily) when added to background therapy of MMF and low-dose corticosteroids, compared to background therapy alone in an ethnically and racially diverse patient population with active LN.

    The AURORA 1 study enrolled 357 patients with a diagnosis of systemic lupus erythematosus (SLE) and LN according to the American College of Rheumatology criteria and a kidney biopsy within two years that showed Class III, IV and/or V LN. The primary endpoint was complete renal response at 52 weeks defined as urine protein creatinine ratio (UPCR) ≤0.5 mg/mg, with stable renal function (defined as estimated glomerular filtration rate [eGFR] ≥60 mL/min/1.73 m2 or no confirmed decrease from baseline in eGFR of >20%), no administration of rescue medication, and no more than 10 mg prednisone equivalent per day for three or more consecutive days or for seven or more days during Weeks 44 through 52. Key secondary hierarchical endpoints were complete renal response (CR) at Week 24 (based on primary endpoint definition with steroid dosing assessed during Weeks 16 through 24), partial renal response (PR), defined as a 50% reduction in UPCR from baseline, at Weeks 24 and 52, time to UPCR of ≤0.5 mg/mg and time to 50% reduction in UPCR from baseline.

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    Aurinia Announces Publication of AURORA 1 Phase 3 Study Results with LUPKYNIS (voclosporin) in The Lancet Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH / TSX: AUP) (“Aurinia” or the “Company”) today announced that The Lancet, an international, peer-reviewed medical journal, published the results of the Company’s Phase 3 AURORA 1 study evaluating LUPKYNIS …