Incurable Lupus Nephritis Treatment 'Lupkynis' Approved by US FDA

Iljin SNT Investment in 'Orinia' Oral Lupus Nephritis Treatment Development
Significantly Improved Efficacy and Reduced Side Effects Compared to Existing Therapies, Patient-Friendly New Drug

[Asia Economy Reporter Kim Jong-hwa] A groundbreaking new drug has been developed that can treat the rare disease lupus nephritis (LN) by taking it twice a day.

Iljin Group announced on the 25th that 'LUPKYNIS,' a lupus nephritis treatment developed by the Canadian pharmaceutical company Aurinia, has been approved by the U.S. FDA.

Aurinia is a Canadian pharmaceutical company listed on the U.S. Nasdaq and the Toronto Stock Exchange (TSX) in Canada, with Iljin Group affiliate 'Iljin S&T' as its largest shareholder. This is not the first success for Iljin Group in bio investments.

In 1990, the U.S. bio venture company ETEX, in which they invested, received FDA approval in 1996 for a new pharmaceutical substance used as a bone substitute, and Aurinia also received FDA approval 11 years after starting investment in 2010.

'LUPKYNIS' is the first oral lupus nephritis treatment approved by the U.S. FDA.

Lupus nephritis occurs when systemic lupus erythematosus (SLE) affects the kidneys. It is an inflammatory disease caused by autoantibodies that arise to combat immune disorders but abnormally activate in organs such as the kidneys, lungs, heart, as well as the circulatory and nervous system tissues. Without proper treatment, 87% of patients progress to end-stage renal failure or death within 10 years, making it a difficult-to-treat disease.

Until now, there were no FDA or European EMA-approved treatments for lupus nephritis, so patients were treated with CellCept (MMF), a drug that alleviates rejection reactions during organ transplantation, combined with steroids.

However, only 10-20% of patients responded effectively, and steroid use caused side effects such as cataracts and worsening of the hip joints.

In a Phase 3 clinical trial, Aurinia reduced the steroid dose used with CellCept (MMF) and combined it with the developing drug LUPKYNIS. Clinical results showed that patients treated with both CellCept and LUPKYNIS had more than twice the kidney response rate compared to those treated with the conventional method, and proteinuria levels decreased more than twice as fast.

The U.S. FDA designated LUPKYNIS as a fast track treatment in 2016 during clinical trials and classified it as a priority review treatment when applying for new drug approval after Phase 3, completing the review four months faster than the average 10 months for general treatments. Priority review treatments are designated by the FDA when significant improvements in safety and efficacy are expected for the prevention, diagnosis, or treatment of serious diseases.

Peter Greenleaf, CEO of Aurinia, said, "This U.S. FDA approval is a groundbreaking turning point for patients with lupus nephritis, their families, caregivers, and medical staff involved with lupus nephritis," adding, "We worked hard to secure an innovative treatment method that guarantees both efficacy and safety, and we have achieved results."

Steven Gibson, President of the U.S. Lupus Foundation, evaluated, "Until now, there was an urgent need for treatments that reduce kidney damage and eliminate the need for kidney transplants. This approval is highly significant as it represents an important advancement in lupus nephritis treatment."

This content was produced with the assistance of AI translation services.