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Aurinia Announces the Great Britain Marketing Authorization of LUPKYNIS® (voclosporin) for the Treatment of Lupus Nephritis
MHRA Approval follows European Commission marketing authorization of LUPKYNIS to treat adults with active lupus nephritis in 27 European Union Member States
About this update from Aurinia Pharmaceuticals Inc
[{"type":"text","content":"\nMHRA Approval follows European Commission marketing authorization of LUPKYNIS to treat adults with active lupus nephritis in 27 European Union Member States\n\nLUPKYNIS is the first oral medicine approved in the U.S. and Europe for the treatment of adults living with active lupus nephritis\n\n VICTORIA, British Columbia--(BUSINESS WIRE)--\n\nAurinia Pharmaceuticals Inc. (NASDAQ:AUPH) (Aurinia or the Company), a biopharmaceutical company committed to delivering therapeutics that change the trajectory of autoimmune disease, announced that the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) has granted the Great Britain marketing authorization of LUPKYNIS® (voclosporin) to treat adults with active lupus nephritis (LN), a serious complication of systemic lupus erythematosus (SLE).\n\n“The MHRA authorization of LUPKYNIS for individuals with lupus nephritis in Great Britain, on the heels of the marketing authorization in the EU, further expands the availability of LUPKYNIS as a treatment option for people with lupus nephritis,” said Peter Greenleaf, President and Chief Executive Officer, Aurinia. “Otsuka has been a valued partner in these efforts, and we are pleased to work with them to reach new patients.”\n\nThe marketing authorization by the MHRA, which follows the European Commission (EC) authorization on September 19, 2022, is based on the Phase 3 AURORA 1 study and the AURORA 2 continuation study, which demonstrated voclosporin, in combination with mycophenolate mofetil (MMF) and low-dose corticosteroids, led to statistically superior complete renal response rates at 52 weeks compared to MMF and low-dose corticosteroids alone. The safety profile of voclosporin and MMF and low-dose corticosteroids was generally comparable to MMF and low-dose corticosteroids alone.\n\nIn addition, a marketing authorization application for LUPKYNIS was submitted to the Swiss Agency for Therapeutic Products (Swissmedic) and is currently under review. Swissmedic previously granted orphan drug status to voclosporin in LN in February 2022.\n\nAurinia and Otsuka Pharmaceutical Co., Ltd., (Otsuka) entered a collaboration and licensing agreement in December 2020 for the development and commercialization of voclosporin for the treatment of LN in the United Kingdom, EU, Japan, Russia, Switzerland, Norway, Belarus, Iceland, Liechtenstein, a...