EU grants approval for Lupkynis in lupus nephritis
Aurinia Pharmaceuticals announced that the European Commission (EC) has granted marketing authorization of Lupkynis (voclosporin) to treat adults with active lupus nephritis (LN), a serious complication of systemic lupus erythematosus (SLE)
The FDA approved Lupkynis on January 22, 2021, in combination with a background immunosuppressive therapy regimen to treat adult patients with active LN.
The EC approval of Lupkynis is based on the results of the pivotal Phase III AURORA 1 study and the recent 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.
A decision on marketing authorization for Lupkynis in Great Britain is expected from the UK Medicines and Healthcare products Regulatory Agency in the coming weeks. In addition, a marketing authorization application (MAA) 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.
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