Express . . . Treatment of lupus nephritis, potential "best-in-class" therapy qualified by the FDA for priority review.

▎ Aurinia announced today that the US Food and Drug Administration (FDA) has accepted a new drug application (NDA) for voclosporin developed by the company as a potential therapeutic drug for lupus nephritis (LN).FDA has granted priority to the NDA and is expected to respond by January 22, 2021. The FDA also informed the company that it did not plan to hold an advisory committee meeting to discuss the application.lupus nephritis is a renal inflammation caused by systemic lupus erythematosus (SLE), which is a manifestation of severe progression of SLE.renal injury in LN patients resulted in proteinuria and / or hematuria, decreased renal function and increased serum creatinine levels.ln can cause permanent and irreversible tissue damage to the kidney, resulting in end-stage renal disease (ESRD). Therefore, LN is a serious life-threatening disease.voclosporin is a potential "best in class" calcineurin inhibitor (CNI).it stabilizes podocyte by inhibiting calcineurin, blocking IL-2 expression and T cell-mediated immune response.compared with traditional CNI, it showed more predictable pharmacokinetic and pharmacodynamic relationships, and improved metabolic characteristics.} the molecular structure of voclosporin (image source: ed (edgar181) / public domain) the NDA of voclosporin is supported by global clinical trial data, including two key clinical studies: Aurora phase 3 and aura-lv phase 2.the results of a key phase 3 clinical trial involving 357 ln patients showed a renal response rate of 40.8% for voclosporin compared with 22.5% in the control group (P & lt; 0.001).at the same time, voclosporin reached all secondary endpoints and showed excellent efficacy in the pre identified subgroup analysis.Mr. Peter Greenleaf, President and chief executive officer of Aurinia, said: "LN patients need an advanced treatment to quickly relieve their condition.we will continue to work with FDA during the review process, while preparing for potential approval and promotion in the first quarter of 2021."reference: [1] Aurinia announcements U.S. Food and Drug Administration acceptance of the filing of new drug application and priority review for voclosporin for the treatment of lupus nephritis. Retrieved July 21, 2020, from note: This article aims to introduce the progress of medical health research, not the recommendation of treatment options.for guidance on treatment plan, please go to a regular hospital.