FDA Approves Aurinia Pharmaceuticals’ LUPKYNIS for Adult Patients with Active Lupus Nephritis

LUPKYNIS (voclosporin) is the first FDA-approved oral therapy for lupus nephritis, a condition that causes irreversible kidney damage and increases the risk of kidney failure, cardiac events, and death.

On Monday, January 25, 2021, Aurinia Pharmaceuticals Inc. announced that the U.S. Food and Drug Administration (FDA) approved LUPKYNIS (voclosporin) to treat adult patients with active lupus nephritis (LN).LUPKYNIS is the first FDA-approved oral therapy for LN. Symptoms and longterm impacts of LN include:

• irreversible kidney damage

• significant increases in the risk of kidney failure

• cardiac events including heart attack

• death

Lupus Nephritis is a serious complication of systemic lupus erythematosus (SLE). 30% - 50% of people with lupus will be diagnosed with LN.

Clinical Trial Overview

During clinical trials, LUPKYNIS was in conjunction with a background immunosuppressive therapy regimen.

Methods

Methods derived from Aurinia’s AURORA Phase 3 study and the AURA-LV Phase 2 study.Study Overview:

• 533 randomized patients

• The studies enrolled patients with LN of Class III or IV (alone or in combination with Class V) or pure Class V

• Participants received either 23.7 mg LUPKYNIS or placebo twice daily

• All participants were dosed with concurrent MMF at a target dose 2 g/day

• Initial treatment on first two days with intravenous (IV) methylprednisolone up to a cumulative dose of 1 g

• All participants given oral corticosteroids

• Participants were required to have baseline eGFR >45 mL/min/1.73 m2

Dosage overview:

• Starting dose of oral prednisone was 20 mg/day for patients with a body weight of <45 kg and 25 mg/day for patients ≥45 kg

• Dose of oral corticosteroid was tapered down to achieve a target dose of 2.5 mg/day by Week 16

Phase III Trial

"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 percent 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 (>3%) 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

• decreased appetite

Lupus Community Feedback

“The LUPKYNIS approval marks a turning point for the lupus nephritis community – patients, caregivers, families, and healthcare professionals – all of whom we thank for their partnership in the development of this innovative novel treatment. We are thrilled to bring LUPKYNIS to the people impacted by this devastating condition,” said Peter Greenleaf, President and Chief Executive Officer of Aurinia Pharmaceuticals.“For years treating patients with lupus nephritis has been challenging. We have had a very limited number of therapeutic options, and these have been only modestly effective but highly toxic," said Brad H. Rovin, M.D., Professor of Medicine and the Director of the Division of Nephrology, Ohio State University Wexler Medical Center, and AURORA clinical trial investigator. “The FDA approval of LUPKYNIS allows us to treat patients safely and more effectively with a rapid acting therapy which requires far less steroids, something our patients will appreciate.”“People with lupus nephritis have desperately needed approved treatments to help them avoid irreversible kidney damage and the eventual need for kidney transplant,” said Stevan W. Gibson, President and CEO, Lupus Foundation of America. “The approval of a tailored therapy represents a significant step forward in treating lupus nephritis and is excellent news for the lupus community.” LUPKYNIS is now available to patients in the United States.For more information about LUPKYNIS, click here.