Late Friday, January 22, Aurinia Pharmaceuticals, one of Arctic Aurora LifeScience’s portfolio holdings, announced that the US FDA has approved Aurinia’s new drug Lupkynis for the use in patients that suffers from lupus nephritis (LN). The approval marks a significant step forward in the management of this progressive and potentially life-threatening disease.

While estimates vary, roughly one million people in the US and EU have lupus (also known as SLE, Systemic Lupus Erythematosus) of which a large majority are women. SLE is an autoimmune disease, whereby the body’s own immune system attacks healthy tissue. Symptoms are diverse, patients may experience skin rash, joint pain, abdominal pain, fatigue, anemia, lung inflammation and heart problems.

30-40% of SLE patients has LN, where the kidneys are being attacked by immune cells and is considered one of the most severe manifestations of SLE. If left unchecked LN can ultimately lead to kidney failure and need for dialysis. In addition, loss of proper kidney function is a risk factor that may lead to heart failure. Steroid treatment and immunosuppressive drugs are commonly used to treat LN, but these therapies are associated with severe side effects and are often limited to short term use for this chronic condition. Hence the unmet need for new effective therapies for LN is large.

The key basis of Lupkynis approval was a Phase 3 clinical study conducted by Aurinia in LN patients where Lupkynis was added on top of standard-of-care treatment and compared to patients receiving placebo plus standard-of-care. After one year, nearly double the number of patients treated with Lupkynis compared to the control arm achieved complete response of kidney function. In addition, Lupkynis treatment was superior in several secondary trial endpoints, such as speed of onset of effect, while safety appeared similar to standard-of-care alone.