Business
Aurinia Announces Positive CHMP Opinion for LUPKYNIS® (voclosporin) for the Treatment of Adults with Active Lupus Nephritis in Europe
Positive CHMP opinion is based on a comprehensive submission including data from the pivotal AURORA 1 efficacy study and the AURORA 2 continuation study,
About this update from Aurinia Pharmaceuticals Inc
[{"type":"text","content":"\nPositive CHMP opinion is based on a comprehensive submission including data from the pivotal AURORA 1 efficacy study and the AURORA 2 continuation study, demonstrating voclosporin to be safe and well tolerated for up to three years of treatment.\n\nBased on the CHMP recommendation, a decision by the European Commission is expected in approximately two months.\n\nLUPKYNIS® was approved by the FDA in 2021 for the treatment of adults with active lupus nephritis and is the first oral therapy available for the treatment of the disease, in the U.S.\n\n VICTORIA, British Columbia--(BUSINESS WIRE)--\nAurinia Pharmaceuticals Inc. (NASDAQ:AUPH) (Aurinia or the Company), a biopharmaceutical company committed to delivering therapeutics that change the course of autoimmune disease, today 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 (LN), a serious complication of systemic lupus erythematosus (SLE). The U.S. Food and Drug Administration (FDA) approved LUPKYNIS (voclosporin) on January 22, 2021, in combination with a background immunosuppressive therapy regimen to treat adult patients with active LN.\n\nIn 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.\n\nBased on the CHMP recommendation, a decision by the European Commission is expected in approximately two months. If granted by the European Commission, the centralized marketing authorization would be valid in all EU member states as well as in Iceland, Liechtenstein, and Norway.\n\n“This positive recommendation brings us one step closer to delivering voclosporin to LN patients across Europe and with a...