Otsuka Pharmaceutical Co., Ltd. (Otsuka) announces that Lupkynis^® (voclosporin) has been launched today for the treatment of lupus nephritis (LN), an inflammation of the kidneys caused by systemic lupus erythematosus, an autoimmune disease.

Lupkynis is a novel, oral immunosuppressive agent developed for the treatment of LN. It suppresses the immune system by inhibiting calcineurin, an enzyme that is crucial for the proliferation and activation of T cells, an important element of the immune system.

In December 2020, Otsuka and Aurinia Pharmaceuticals Inc. entered into a collaboration and license agreement for the development and commercialization of oral voclosporin for the treatment of LN in Japan and European countries.

In September 2022 Otsuka received European Commission approval for Lupkynis as a treatment for active LN in EU member countries. Otsuka subsequently received approval for Lupkynis in Japan in Septermber this year.

In the U.S., Aurinia received FDA marketing approval in January 2021 for Lupkynis as a treatment for active LN in adults.

Otsuka Pharmaceutical is committed to research and development that contributes to patients and their families in order to meet unmet medical needs worldwide. Our research priorities, in addition to autoimmune diseases, include mental, renal and cardiovascular health, and the often-ignored disease tuberculosis.