Lupkynis (Voclosporin) Approved in Japan for Lupus Nephritis Treatment
Key Insights
The Japanese Ministry of Health, Labour, and Welfare approved Lupkynis (voclosporin) in combination with mycophenolate mofetil for treating lupus nephritis (search).
This approval was based on the AURORA Clinical Program, which demonstrated Lupkynis' efficacy and safety in treating lupus nephritis (search) patients.
Aurinia Pharmaceuticals is eligible to receive a $10 million payment from Otsuka Pharmaceutical (search), along with royalties on net sales, following the approval.
The Japanese Ministry of Health, Labour, and Welfare has approved Lupkynis (voclosporin) for the treatment of lupus nephritis (search) (LN), a complication of lupus (search) characterized by kidney damage and inflammation. The approval allows for the use of Lupkynis in combination with mycophenolate mofetil. This decision marks a significant step forward in addressing the unmet needs of Japanese lupus nephritis patients, who experience a high rate of the condition.
The approval was based on the AURORA Clinical Program, which included the Phase 3 AURORA clinical trial and its extension study, AURORA 2. These studies evaluated the efficacy and safety of voclosporin when used with mycophenolate mofetil and low-dose glucocorticoids, compared to using mycophenolate mofetil and low-dose glucocorticoids alone. The data demonstrated that Lupkynis significantly improved kidney function stabilization after one year.
Strategic Partnership and Financial Implications
Otsuka Pharmaceutical (search) Co., Ltd., which holds the development and marketing rights to Lupkynis in Japan and other countries through a licensing agreement with Aurinia Pharmaceuticals Inc., filed the new drug application in November 2023. With this approval, Aurinia is set to receive a $10 million payment from Otsuka, in addition to low double-digit royalties on net sales once the product is launched. Aurinia will supply the oral therapy to Otsuka to support the market launch in Japan.
Peter Greenleaf, President and CEO of Aurinia, stated, "We are thrilled to achieve this milestone that will provide access to LUPKYNIS in Japan, where there is a high rate of lupus nephritis (search) among Japanese lupus (search) patients. Our successful strategic partnership with Otsuka has allowed us to bring LUPKYNIS to LN patients across Europe and now Japan, addressing a significant unmet need."
Mechanism of Action and Global Approvals
Lupkynis is designed to reduce inflammation associated with lupus nephritis (search) and support kidney cell health and function. It functions by inhibiting calcineurin (search), a protein that activates T-cells involved in inflammation. Besides Japan, Lupkynis has also been approved for treating active lupus nephritis in the U.S., the U.K., the European Union, and Switzerland.
About Lupus Nephritis
Lupus nephritis (search) is a severe complication of systemic lupus (search) erythematosus (SLE), an autoimmune disease. In LN, the immune system attacks the kidneys, leading to inflammation and potential kidney failure if untreated. Medical guidelines emphasize routine screening for LN in SLE patients due to the prognostic impact of delayed diagnosis. Approximately 120,000 people in the U.S. are affected by LN, with a disproportionate impact on women and people of color.