Aurinia Pharmaceuticals (NASDAQ:AUPH), has announced that Japan’s Ministry of Health, Labour, and Welfare (MHLW) has approved voclosporin, a second-generation calcineurin inhibitor (CNI), in combination with mycophenolate mofetil (MMF), for the treatment of lupus nephritis (LN).
Voclosporin, currently available in the U.S. under Aurinia’s brand name LUPKYNIS, is FDA-approved for use in combination with a background immunosuppressive therapy regimen for the treatment of adult patients with active LN.
The MHLW approval is supported by data from the AURORA Clinical Program, which included a 12-month, Phase 3, double-blind, randomized-controlled trial, as well as a two-year extension study, evaluating the efficacy and safety of voclosporin with MMF and low-dose glucocorticoids compared to MMF and low-dose glucocorticoids alone in LN patients.
“We are thrilled to achieve this milestone that will provide access to LUPKYNIS in Japan, where there is a high rate of LN among Japanese lupus 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,” said Peter Greenleaf, president, and CEO of Aurinia.
Aurinia’s collaboration partner, Otsuka Pharmaceutical, filed the NDA with Japanese regulatory authorities in November 2023. Aurinia and Otsuka entered into a collaboration and licensing agreement in December 2020 for the development and commercialization of oral voclosporin in the EU, Japan, the United Kingdom, Russia, Switzerland, Norway, Belarus, Iceland, Liechtenstein, and Ukraine.
