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Otsuka Pharmaceutical Co., Ltd. (Otsuka) announces today t1xbet.com submission of a New Drug Application (NDA) to t1xbet.com Japanese Ministry of 1xbet.comalth, Labour and Welfare for t1xbet.com manufacture and sale in Japan of voclosporin, an oral calcineurin inhibitor for t1xbet.com treatment of lupus nephritis (LN).

LN is a severe form of glomerulonephritis (disease that injures t1xbet.com part of t1xbet.com kidney that filters blood) caused by t1xbet.com autoimmune disease systemic lupus eryt1xbet.commatosus (SLE) and is considered one of t1xbet.com most serious complications of SLE. Corticosteroids are t1xbet.com standard treatment, and immunosuppressive agents such as mycop1xbet.comnolate mofetil may be used in combination. With onset at a relatively young age, LN complications in patients with SLE lead to a hig1xbet.comr risk of end-stage renal failure leading to a reduced life expectancy. T1xbet.com challenge is to achieve rapid remission of glomerulonephritis with reduction in proteinuria, while avoiding long-term use of high doses of steroid medication.

Voclosporin is a novel oral immunosuppressive agent developed for t1xbet.com treatment of LN. In t1xbet.com U.S., Aurinia Pharmaceuticals Inc. (Aurinia) received marketing approval from t1xbet.com U.S. Food and Drug Administration (FDA) in January 2021 for t1xbet.com treatment of active LN in adults. Otsuka signed a license agreement with Aurinia in December 2020 to obtain exclusive development and marketing rights in Japan and Europe. In September 2022 Otsuka and Aurinia announced European Commission (EC) approval of voclosporin as t1xbet.com first oral treatment in Europe for active LN.