Aurinia Pharmaceuticals (NASDAQ:AUPH) Inc. and its partner, Otsuka Pharmaceutical Co. Ltd., have submitted a New Drug Application (NDA) to the Japanese Ministry of Health for voclosporin, an oral treatment designed for lupus nephritis, a debilitating kidney condition associated with systemic lupus erythematosus.
The submission marks a significant milestone in the partnership between the Canadian biopharmaceutical company and the Japanese pharmaceutical giant, which began with a licensing agreement signed in December 2020. Under this agreement, the two companies have collaborated on the development and commercialization of voclosporin in various markets, including Japan.
The U.S. Food and Drug Administration (FDA) previously approved voclosporin in January 2021, and it is currently marketed in the United States under the brand name Lupkynis for systemic lupus erythematosus treatment.
Should the Japanese health authorities approve voclosporin, Aurinia stands to gain financially from the arrangement with Otsuka. The company is poised to receive a $10 million payment upon approval and will also earn low double-digit royalties on net sales of the drug in Japan.
This latest development represents an opportunity to expand the global reach of voclosporin and offer a new therapeutic option to lupus nephritis patients in Japan, pending regulatory approval. The partnership underscores a shared commitment by Aurinia and Otsuka to address unmet medical needs within the field of autoimmune diseases.
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