FDA Approves Voclosporin for Lupus Nephritis

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The treatment represents the first ever oral therapy approved by the FDA for lupus nephritis.

The US Food and Drug Administration (FDA) has approved voclosporin (LUPKYNIS) to treat patients with active lupus nephritis.

The approval, representing the first FDA-approved oral therapy for lupus nephritis, allows Aurinia Pharmaceuticals to move forward with the treatment in combination with a background immunosuppressive therapy regiment for adult patients.

The Trial

Researchers found patients treated with voclosporin in combination with standard-of-care were more than twice as likely to achieve renal response and experience a decline in urine protein creatinine ratio twice as fast as patients on typical standard-of-care alone in clinical trials.

Patients treated with the study drug also showed improved response rates in all parameters across immunologically-active classes of lupus nephritis studied.

The Need

“For years treating patients with lupus nephritis has been challenging,” Brad H. Rovin, MD, Professor of Medicine and the Director of the Division of Nephrology, Ohio State University Wexler Medical Center, and AURORA clinical trial investigator, said in a statement. “We have had a very limited number of therapeutic options, and these have been only modestly effective but highly toxic. “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.”

Lupus nephritis can cause irreversible kidney damage, while significantly increasing the risk of kidney failure, cardiac events, and death for patients. The disorder is considered 1 of the most serious and common complications of systemic lupus erythematosus (SLE).

Aurinia has also launched Aurinia Alliance, a patient support program featuring nurse case managers who provide personalized educational resources and assistance in navigating insurance and medication costs.