Research & Development
Aurinia receives FDA's approval for LUPKYNIS for treating adult patients with Active Lupus Nephritis
25 January 2021 -

Biopharmaceutical company Aurinia Pharmaceuticals Inc (NASDAQ:AUPH) (TSX:AUP) reported on Friday the receipt of first approval from the US Food and Drug Administration (FDA) under priority review and fast track designation for the oral therapy LUPKYNIS (voclosporin) in combination with a background immunosuppressive therapy regimen to treat adult patients with active lupus nephritis (LN).

Lupus nephritis (LN) is a serious progression of SLE, a chronic, complex and autoimmune disease. If poorly controlled, LN can lead to permanent and irreversible tissue damage within the kidney, resulting in kidney failure.

Under the company's pivotal pivotal AURORA Phase 3 study and the AURA-LV Phase 2 study, about 533 LN patients were 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.

All patients were dosed in the pivotal studies at a target dose 2 g/day. These studies together demonstrated the ability of LUPKYNIS treatment to significantly improve outcomes as reported up to 52 weeks and the patients treated with LUPKYNIS showed improved response rates in all parameters across immunologically-active classes of LN studied, revealed the company

In conjunction, the company has developed and launched Aurinia Alliance, a patient support program featuring dedicated nurse case managers who provide personalized educational resources and assistance in navigating insurance and Aurinia medication costs throughout each patient's LUPKYNIS treatment journey.



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