By Chris Wack
Aurinia Pharmaceuticals said Monday that collaboration partner Otsuka Pharmaceutical filed a new drug application for voclosporin for the treatment of lupus nephritis with the Japanese Ministry of Health, Labor and Welfare.
The NDA is for the manufacture and sale in Japan of voclosporin, a second-generation oral calcineurin inhibitor for the treatment of lupus nephritis, a complication of the autoimmune disease systemic lupus erythematosus that impacts the kidneys.
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.
In January 2021, the U.S. Food and Drug Administration 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.
Aurinia and Otsuka entered a collaboration and licensing agreement in December 2020 for the development and commercialization of voclosporin for the treatment of LN in the EU, Japan, the U.K., Russia, Switzerland, Norway, Belarus, Iceland, Liechtenstein and Ukraine.
Write to Chris Wack at [email protected]
Read the full article here
