25 January 2021 - - The U.S. Food and Drug Administration has approved Lupkynis (voclosporin) in combination with a background immunosuppressive therapy regimen to treat adult patients with active lupus nephritis, Canada-based Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) (TSX: AUP) said.

Lupkynis is the first FDA-approved oral therapy for LN. LN 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. Lupkynis is now available to patients in the United States.

In pivotal trials, patients treated with Lupkynis in combination with standard-of-care 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.

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.

To assist Lupkynis patients and the healthcare provider who prescribe the treatment, Aurinia 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.

Lupkynis was approved by the FDA under Priority Review and was previously granted Fast Track designation from the Agency in 2016.

The approval of Lupkynis is based on data from Aurinia's pioneering late-stage global clinical studies in LN the pivotal AURORA Phase 3 study and the AURA-LV Phase 2 study.

These studies together demonstrated the ability of LUPKYNIS treatment to significantly improve outcomes as reported up to 52 weeks, for patients on several parameters when added to the typical SoC, mycophenolate mofetil, and low dose steroids.

In both studies, a total of 533 patients with LN were randomized to receive either LUPKYNIS 23.7 mg or placebo twice daily used with SoC.

All patients were dosed with concurrent MMF at a target dose 2 g/day. In both studies, initial treatment with intravenous methylprednisolone up to a cumulative dose of 1 g was administered on Days 1 and 2, and all patients received a subsequent taper of oral corticosteroids.

The starting dose of oral prednisone was 20 mg/day for patients with a body weight of 45 mL/min/1.73 m2.

In the Phase 3 study, at one year, Lupkynis plus SoC was more than two times as effective at achieving a complete renal response than the SoC alone.

Patients in the study taking Lupkynis also achieved a 50% reduction in UPCR twice as fast as SoC, and a higher portion of Lupkynis-treated patients achieved a complete renal response at 24 weeks compared to patients receiving SoC. The study results were achieved using a protocol-defined steroid taper.

Patients treated with Lupkynis showed improved response rates in all parameters across immunologically-active classes of LN studied.

The most common adverse reactions were glomerular filtration rate decreased, hypertension, diarrhea, headache, anemia, cough, urinary tract infection, abdominal pain upper, dyspepsia, alopecia, renal impairment, abdominal pain, mouth ulceration, fatigue, tremor, acute kidney injury, and decreased appetite.

Lupus nephritis is a serious progression of SLE, a chronic, complex and autoimmune disease.

About 200,000-300,000 people live with SLE in the U.S. and approximately one out of three of these individuals have already developed LN at the time of SLE diagnosis.

If poorly controlled, LN can lead to permanent and irreversible tissue damage within the kidney, resulting in kidney failure.

Black and Asian individuals with SLE are four times more likely to develop LN and individuals with Hispanic ancestry are approximately twice as likely to develop the disease when compared with Caucasian individuals. Black and Hispanic individuals with SLE also tend to develop LN earlier and have poorer outcomes when compared to Caucasian individuals.