Otsuka Pharmaceutical Co., Ltd.

November 10, 2023

Otsuka Submits New Drug Application in Japan for Voclosporin
in the Treatment of Patients with Lupus Nephritis

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

LN is a severe form of glomerulonephritis (disease that injures the part of the kidney that filters blood) caused by the autoimmune disease systemic lupus erythematosus (SLE) and is considered one of the most serious complications of SLE. Corticosteroids are the standard treatment, and immunosuppressive agents such as mycophenolate mofetil may be used in combination. With onset at a relatively young age, LN complications in patients with SLE lead to a higher risk of end-stage renal failure leading to a reduced life expectancy. The 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 the treatment of LN. In the U.S., Aurinia Pharmaceuticals Inc. (Aurinia) received marketing approval from the U.S. Food and Drug Administration (FDA) in January 2021 for the 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 the first oral treatment in Europe for active LN.