Aurinia Pharmaceuticals and Its Collaborative Partner, Otsuka, Have Jointly Filed a New Drug Application (NDA) for LUPKYNIS® (Voclosporin) in Japan

Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) has reported that Otsuka Pharmaceutical Ltd., its collaboration partner, submitted a new drug application (NDA) to the Japanese Ministry of Health, Labour, and Welfare for the manufacture and sale of voclosporin in Japan. Voclosporin, a second-generation oral calcineurin inhibitor, aims to treat lupus nephritis (LN), a kidney complication associated with systemic lupus erythematosus (SLE). The U.S. Food and Drug Administration (FDA) previously granted approval to voclosporin in January 2021 for the treatment of active LN in combination with background immunosuppressive therapy, available in the U.S. as LUPKYNIS®.

Aurinia and Otsuka established a collaboration and licensing agreement in December 2020 to jointly develop and commercialize voclosporin for LN treatment in various regions, including Japan. Upon approval in Japan, Aurinia is set to receive a $10 million payment along with low double-digit royalties on net sales upon launch.

Peter Greenleaf, President, and CEO of Aurinia Pharmaceuticals, highlighted the severity of lupus nephritis and the necessity for advanced therapies prioritizing kidney preservation. The collaboration aims to make voclosporin more widely available, addressing a significant unmet need in lupus nephritis.

Lupus nephritis is a severe manifestation of systemic lupus erythematosus, affecting approximately 200,000-300,000 individuals with SLE in the U.S. About one-third of those diagnosed with SLE develop lupus nephritis, which, if poorly controlled, can lead to permanent and irreversible kidney tissue damage. Certain demographic groups, such as Black, Asian, and Hispanic individuals, face a higher risk of developing LN, with disparities in outcomes compared to Caucasian individuals.

LUPKYNIS® is the first oral medicine approved by the U.S. FDA and the European Commission for treating adult patients with active lupus nephritis. It is a structurally modified calcineurin inhibitor with a dual mechanism of action, suppressing T cell activation and cytokine production while promoting podocyte stability in the kidney. The recommended starting dose of LUPKYNIS is three capsules twice daily, and dose adjustments can be made based on Aurinia's personalized dosing protocol. The product carries boxed warnings and precautions consistent with other calcineurin inhibitor-immunosuppressive treatments.

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