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The Food and Drug Administration (FDA) will give Priority Review to the New Drug Application (NDA) of voclosporin (Aurinia Pharmaceuticals) for the treatment of lupus nephritis.
Voclosporin, a novel calcineurin inhibitor, works by blocking interleukin (IL)-2 expression and T-cell mediated immune responses and stabilizing the podocyte in the kidney. The NDA is supported by data from the pivotal phase 3 AURORA and phase 2 AURA-LV studies.