Aurinia Pharmaceuticals partner Otsuka files NDA in Japan for Lupkynis

Aurinia Pharmaceuticals’ collaboration partner, Otsuka Pharmaceutical, filed a NDA for voclosporin – Lupkynis – for the treatment of lupus nephritis with the Japanese Ministry of Health, Labour, and Welfare for the manufacture and sale in Japan of voclosporin, a second-generation oral calcineurin inhibitor for the treatment of lupus nephritis. LN is a complication of the autoimmune disease systemic lupus erythematosus that seriously impacts the kidneys. In January 2021, the FDA approved voclosporin in combination with a background immunosuppressive therapy regimen for the treatment of adult patients with active LN and it is currently available in the U.S. under the brand name Lupkynis. Aurinia and Otsuka entered a collaboration and licensing agreement in December 2020 for the development and commercialization of voclosporin for the treatment of LN in the EU, Japan, the United Kingdom, Russia, Switzerland, Norway, Belarus, Iceland, Liechtenstein, and Ukraine. As part of the agreement, Aurinia is eligible to receive a payment of $10M upon approval in Japan along with low double-digit royalties on net sales once launched.