Encouraging Phase II Data Boost the Prospects of Voclosporin for Lupus Nephritis

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On December 13, 2016, Aurinia Pharmaceuticals received the FDA minutes from their Phase IIb meeting about the future market approval of voclosporin for the treatment of lupus nephritis (LN). Despite the setbacks from unexpected deaths in the voclosporin treatment arm in the recent Phase IIb AURORA-LV study, GlobalData expects that the encouraging data on prolonged stable renal function, together with its improved safety profile, will fill the need for new drugs in LN—a disease where half of all patients fail to see symptom relief from the current standard of care. It comes as no surprise that the Canada-based biotech will proceed with Phase III studies to support an eventual New Drug Application (NDA) for voclosporin, as the investigational drug was granted the FDA’s coveted Fast Track designation in March 2016...

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