Otsuka Pharmaceuticals Europe Files MAA with EMA for Voclosporin

Otsuka Pharmaceuticals Europe, a subsidiary of Otsuka Pharmaceuticals Co., Ltd., has filed an initial marketing authorization application (MAA) to the European Medicines Agency (EMA) for voclosporin—an investigational, oral calcineurin inhibitor.

According to a June 25, 2021 press release, the European MAA has been submitted for voclosporin to be used as a treatment of lupus nephritis (LN), a complication of the autoimmune disease systemic lupus erythematosus (SLE). The drug is administered orally and works by inhibiting calcineurin, an enzyme that is important for the proliferation and activation of T-cells.

In December 2020, Aurinia Pharmaceuticals and Otsuka Pharmaceuticals entered a collaboration and license agreement for the development and commercialization of oral voclosporin as a treatment for LN in the European Union, Japan, United Kingdom, Russia, Switzerland, Norway, Belarus, Iceland, Liechtenstein, and Ukraine. FDA has also approved, in January 2021, voclosporin in combination with a background immunosuppressive therapy regimen for the treatment of adults with active LN.