Aurinia Announces Approval Of LUPKYNIS In Japan - Quick Facts

(RTTNews) - Aurinia Pharmaceuticals (AUPH) announced that the Japanese Ministry of Health, Labour, and Welfare has approved LUPKYNIS or voclosporin, a second-generation calcineurin inhibitor, in combination with mycophenolate mofetil to treat lupus nephritis.

The company's collaboration partner, Otsuka Pharmaceutical, filed the new drug application with Japanese regulatory authorities in November 2023. Aurinia and Otsuka entered a collaboration and licensing agreement in 2020 for the development and commercialization of oral voclosporin in the EU, Japan, the United Kingdom, Russia, Switzerland, Norway, Belarus, Iceland, Liechtenstein, and Ukraine. Aurinia is eligible to receive a payment of $10 million upon approval in Japan along with low double-digit royalties on net sales once launched.

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