CHMP positive recommendation for Lupkynis to treat lupus nephritis
Aurinia Pharmaceuticals Inc., has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending voclosporin (brand name, Lupkynis) for marketing authorization to treat adults with active lupus nephritis, a serious complication of systemic lupus erythematosus (SLE)
The FDA approved Lupkynis (voclosporin) on January 22, 2021, in combination with a background immunosuppressive therapy regimen to treat adult patients with active LN.
In December 2020, Aurinia entered into a collaboration and licensing agreement with Otsuka Pharmaceutical Co., Ltd., (Otsuka) for the development and commercialization of voclosporin for the treatment of LN in the European Union, Japan, the United Kingdom, Russia, Switzerland, Norway, Belarus, Iceland, Liechtenstein, and Ukraine. In June 2021, Otsuka’s European subsidiary, Otsuka Pharmaceutical Europe Ltd. (OPEL), an affiliate of Otsuka, filed an initial Marketing Authorization Application (MAA) for voclosporin for the treatment of LN to the EMA. In February 2022, Swiss Medic granted Otsuka orphan drug status for voclosporin in LN.
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