FDA clears Lupkynis, first oral treatment for lupus nephritis

FDA has approved the first oral treatment for lupus nephritis, voclosporin (Lupkynis, Aurinia Pharmaceuticals), used in combination with a background immunosuppressive therapy regimen.

The medication is available immediately to patients in the U.S.

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“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 director of the Division of Nephrology at Ohio State University Wexler Medical Center and the medication’s clinical trial investigator, in a press release.

“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,” Rovin added.

In clinical 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 as the patients receiving standard of care without the new drug.

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Early intervention and kidney response are linked to better long-term outcomes and prevent irreversible kidney damage, said the press release from Aurinia. Patients treated with Lupkynis showed improved response rates in all parameters across immunologically active classes of lupus nephritis studied.

“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,” said Peter Greenleaf, president and CEO of Aurinia Pharmaceuticals. “The approved label supports the efficacy and safety of Lupkynis as well as Aurinia’s proprietary and patented eGFR pharmacodynamic dosing protocol.”

Aurinia 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.

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