Aurinia Pharmaceuticals (AUPH) responded to a now retracted LinkedIn post referencing voclosporin by an FDA official. “Aurinia stands behind the favorable benefit/risk profile of LUPKYNIS. LUPKYNIS received full approval from the FDA in January 2021 based on a large, randomized 52-week clinical study known as AURORA 1. Furthermore, the FDA approved a supplementary new drug application for the long-term use of LUPKYNIS in April 2024 based on the results of AURORA 2, which demonstrated sustained efficacy of LUPKYNIS over a three-year period, with safety comparable to AURORA 1.”
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