FDA approves Aurinia's Lupkynis for active lupus nephritis

The US Food and Drug Administration has approved Lupkynis (voclosporin) in combination with a background immunosuppressive therapy regimen to treat adult patients with active lupus nephritis (LN), developed by Canadian immunology specialist Aurinia Pharmaceuticals (TSX: AUP), whose shares shot up 42% to C$21.10 in pre-market trading this morning.

Lupkynis is an oral therapy for LN, which causes irreversible kidney damage and significantly increases the risk of kidney failure, cardiac events, and death. It is one of the most serious and common complications of the autoimmune disease systemic lupus erythematosus (SLE). Lupkynis is now available to patients in the USA.

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.