Press release
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Aurinia NEWS RELEASE FDA Approves Aurinia Pharmaceuticals ' LUPKYNIS TM ( voclosporin ) for Adult Patients with Active Lupus Nephritis - LUPKYNIS is the first FDA - approved oral therapy for lupus nephritis ( LN ) , a condition that causes irreversible kidney damage and increases the risk of kidney failure , cardiac events , and death - -LUPKYNIS demonstrated significantly improved renal response rates compared to typical standard - of - care ( SoC ) in clinical trials -LUPKYNIS is now commercially available in the U.S. - - Multimedia components are available with this press release ( link here ) - - Conference call to be hosted Monday , January 25 , 2021 , 8:30 a.m. ET- VICTORIA , British Columbia and ROCKVILLE , Maryland - January 22 , 2021 - Aurinia Pharmaceuticals Inc. ( NASDAQ : AUPH / TSX : AUP ) ( " Aurinia " or the " Company " ) today announced that the U.S. Food and Drug Administration ( FDA ) has approved LUPKYNISTM ( voclosporin ) in combination with a background immunosuppressive therapy regimen to treat adult patients with active lupus nephritis ( LN ) . LUPKYNIS is the first FDA - approved oral therapy for LN . LN causes irreversible kidney damage and significantly increases the risk of kidney failure , cardiac events , and death . It is one of the most serious and common complications of the autoimmune disease systemic lupus erythematosus ( SLE ) . LUPKYNIS is now available to patients in the United States ( U.S. ) . In pivotal trials , patients treated with LUPKYNIS in combination with standard - of - care ( SoC ) were more than twice as likely to achieve renal response and experienced a decline in urine protein creatinine ratio ( UPCR ) twice as fast as patients on typical SoC alone . UPCR is a standard measurement used to monitor protein levels in the kidney . Early intervention and kidney response are linked to better long- term outcomes and prevent irreversible kidney damage . Patients treated with LUPKYNIS showed improved response rates in all parameters across immunologically - active classes of LN studied . " The LUPKYNIS approval marks a turning point for the lupus nephritis community - patients , caregivers , families , and healthcare professionals - all of whom we thank for their partnership in the development of this innovative novel treatment . We are thrilled to bring LUPKYNIS to the people impacted by this devastating condition , " said Peter Greenleaf , President and Chief Executive Officer of Aurinia Pharmaceuticals . " The approved label supports the efficacy and safety of LUPKYNIS as well as Aurinia's proprietary and patented eGFR pharmacodynamic dosing protocol . We have worked tirelessly to put the correct team and infrastructure in place to ensure we are ready for swift commercial adoption of LUPKYNIS . " " For years treating patients with lupus nephritis has been challenging . We have had a very limited number of therapeutic options , and these have been only modestly effective but highly toxic , " said Brad H. Rovin , M.D. , Professor of Medicine and the Director of the Division of Nephrology , Ohio State University Wexler Medical Center , and AURORA clinical trial investigator . " The FDA approval of