Aurinia Pharmaceuticals announced that the Swiss Agency for Therapeutic Products (Swissmedic) has granted marketing authorization of LUPKYNIS® (voclosporin) in combination with a background immunosuppressive therapy to treat adults with active class III, IV and V (including mixed classes III/V and IV/V) lupus nephritis (LN), a serious complication of systemic lupus erythematosus (SLE). In addition, the product received Orphan Drug designation in Switzerland, granting 15 years of drug exclusivity protection in association with approval.
The marketing authorization by Swissmedic, 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, and maintained stable eGFR (estimated glomerular filtration rate) over 3 years. The safety profile of voclosporin and MMF and low-dose corticosteroids was generally comparable to MMF and low-dose corticosteroids alone.
Aurinia and Otsuka Pharmaceutical Co., Ltd., (Otsuka) entered into a collaboration and licensing agreement in December 2020 for the development and commercialization of voclosporin for the treatment of LN in the United Kingdom, European Union, Japan, Russia, Switzerland, Norway, Belarus, Iceland, Liechtenstein, and Ukraine.