Aurinia Says Its Partner Otsuka Filed NDA For Voclosporin In Japan

(RTTNews) - Aurinia Pharmaceuticals Inc. (AUPH) Monday said Otsuka Pharmaceutical Ltd. has filed a new drug application (NDA) for voclosporin for the treatment of lupus nephritis (LN) with the Japanese Ministry of Health, Labour, and Welfare.

Lupus nephritis is a type of kidney disease caused by systemic lupus erythematosus (SLE), an auto immune disease.

In 2020, Aurinia and Otsuka had entered into an agreement for the development and commercialization of voclosporin for the treatment of LN 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 $10 million upon approval of voclosporin in Japan, and also low double-digit royalties on net sales.

In 2021, Voclosporin, in combination with a background immunosuppressive therapy regimen, is approved in the U.S to treat adults with LN.