Aurinia Pharmaceuticals announces Japan MHLW approval for voclosporin

Aurinia Pharmaceuticals announced that the Japanese Ministry of Health, Labour, and Welfare has approved voclosporin, a second-generation calcineurin inhibitor, in combination with mycophenolate mofetil, or MMF, to treat lupus nephritis, or LN. The company’s collaboration partner, Otsuka Pharmaceutical, filed the new drug application, or NDA, with Japanese regulatory authorities in November 2023. The approval is based on data from the AURORA Clinical Program, which included a 12-month, Phase 3, double-blind, randomized-controlled study, as well as a two-year extension study, assessing the efficacy and safety of voclosporin with MMF and low-dose glucocorticoids, compared to MMF and low-dose glucocorticoids alone, in LN patients. Aurinia and Otsuka entered 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. 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. The company will supply product to Otsuka to support the launch under the associated commercial supply agreement on a cost-plus basis.