<이미지를 클릭하시면 크게 보실 수 있습니다>

Canada-based Aurinia Pharmaceuticals Inc. has received marketing authorization of Lupkynis (voclosporin) from the U.S. Food and Drug Administration (FDA), South Korea’s Iljin Group said on Monday.

The Korean business group’s Iljin SNT that mainly invests in life science companies such as drug makers is the largest shareholder of Aurinia whose shares are traded on Nasdaq and TSX exchanges.

Lupkynis is the first FDA-approved oral therapy for lupus nephritis. Lupus is a systemic autoimmune disease that occurs when the body’s immune system attacks organs and tissues. Lupus nephritis, when the immune system attacks kidneys, can lead to permanent and irreversible tissue damage, resulting in kidney failure or death, if poorly controlled.

There is no cure for lupus nephritis, forcing patients to rely on antirejection medicine Cellcept in combination with steroid therapy.

But this standard-of-care (SoC) was only effective in 10 to 20 percent of patients and the use of steroids caused side effects such as cataract or hip joint deterioration, said an Iljin Group official.


In pivotal Phase 3 trials, patients treated with Lupkynis in combination with Cellcept plus reduced steroid regimen were more than twice as likely to achieve renal response and experienced a decline in urine protein creatinine ratio twice as fast as patients on typical SoC alone.

The approval marks a turning point for the lupus nephritis community – patients, caregivers, families, and healthcare professionals, said Peter Greenleaf, Chief Executive Officer of Aurinia Pharmaceuticals, adding the approved label supports the efficacy and safety of Lupkynis.

Stevan W. Gibson, President and CEO, Lupus Foundation of America, welcomed the news by saying the approval represents a significant step forward in treating lupus nephritis. People with lupus nephritis have desperately needed approved treatments to help them avoid irreversible kidney damage and the eventual need for kidney transplant, he added.

[ⓒ Maeil Business Newspaper & mk.co.kr, All rights reserved]