ROCKVILLE, Md. & EDMONTON, Alberta–(BUSINESS WIRE)–Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) today responded to a now retracted LinkedIn post referencing voclosporin by an FDA official.
Aurinia stands behind the favorable benefit/risk profile of LUPKYNIS® (voclosporin). 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.
Please see Prescribing Information, including Boxed Warning, for LUPKYNIS.
About Aurinia
Aurinia is a biopharmaceutical company focused on delivering therapies to people living with autoimmune diseases with high unmet medical needs. In January 2021, the Company introduced LUPKYNIS® (voclosporin), the first FDA-approved oral therapy for the treatment of adult patients with active lupus nephritis. Aurinia is also developing aritinercept (AUR200), a dual inhibitor of B cell-activating factor (BAFF) and a proliferation-inducing ligand (APRIL) for the potential treatment of autoimmune diseases.
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