On Jan. 22, 2021, Aurinia Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA)  had approved LUPKYNISTM (voclosporin) in combination with a background immunosuppressive therapy regimen to treat adult patients with active lupus nephritis (LN).

In pivotal trials, patients treated with LUPKYNIS in combination with standard-of-care (SoC) were more than twice as likely to achieve renal response and experienced a decline in urine protein creatinine ratio (UPCR) twice as fast as patients on typical SoC alone. UPCR is a standard measurement used to monitor protein levels in the kidney. Early intervention and kidney response are linked to better long-term outcomes and prevent irreversible kidney damage. Patients treated with LUPKYNIS showed improved response rates in all parameters across immunologically-active classes of LN studied.

LUPKYNIS was the first FDA-approved oral therapy for LN which causes irreversible kidney damage and significantly increases the risk of kidney failure, cardiac events, and death.