New drug application is filed in Japan for Lupkynis (voclosporin) to treat Lupus Nephritis
Aurinia Pharmaceuticals Inc.announced that the Company’s collaboration partner, Otsuka Pharmaceutical Ltd., filed a new drug application (NDA) for voclosporin for the treatment of lupus nephritis (LN) 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)
LN is a complication of the autoimmune disease systemic lupus erythematosus (SLE) 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.