2021-01-24 14:55:26 AUPH Aurinia Pharmaceuticals
01/24/21 01/2414:55 01/24/2114:55 | FDA approves Aurinia's LUPKYNIS for adult patients with active lupus nephritisAurinia Pharmaceuticals announced that the U.S. Food and Drug Administration has approved LUPKYNISTM in combination with a background immunosuppressive therapy regimen to treat adult patients with active lupus nephritis. LUPKYNIS is the first FDA-approved oral therapy for LN. In pivotal trials, patients treated with LUPKYNIS in combination with standard-of-care were more than twice as likely to achieve renal response and experienced a decline in urine protein creatinine ratio twice as fast as patients on typical SoC alone. Patients treated with LUPKYNIS showed improved response rates in all parameters across immunologically-active classes of LN studied. LUPKYNIS was approved by the FDA under Priority Review and was previously granted Fast Track designation from the Agency in 2016. |
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