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News|Articles|June 29, 2021
Otsuka Pharmaceuticals Europe Files MAA with EMA for Voclosporin
Author(s)Pharmaceutical Technology Editors
Otsuka Pharmaceuticals Europe has filed an initial marketing authorization application to the European Medicines Agency for voclosporin.
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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.
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