FDA Approves First Oral Medication for Lupus Nephritis
The US Food and Drug Administration (FDA) announced January 22 that it has approved Lupkynis (voclosporin) for treatment of active lupus nephritis (LN) among adult patients, in combination with a background immunosuppressive therapy regimen
Lupkynis is the first oral therapy approved for LN, one of the most serious and common complications of systemic lupus erythematosus (SLE).
In the pivotal AURORA phase 3 study as well as the AURA-LV phase 2 study, patients treated with voclosporin combined with intravenous methylprednisolone and mycophenolate mofetil (MMF) exhibited decreases in urine protein creatinine ratio (UPCR) twice as quickly as patients on the usual standard of care alone. These patients also experienced renal response more than 2 times faster than those on standard of care without voclosporin.
In both studies, all 533 participants enrolled received initial intravenous methylprednisolone up to a cumulative dose of 1 g on days 1 and 2, followed by a taper of oral corticosteroids. All patients were also treated with 2 g per day of MMF. The patients were randomized to receive either voclosporin 23.7 mg or placebo twice daily.
These studies together demonstrated the ability of voclosporin treatment to significantly improve outcomes as reported up to 52 weeks, for patients on several parameters when added to the typical standard of care and low-dose steroids.
At 52 weeks, the phase 3 study results indicated that participants who received voclosporin had twice the rate of a complete renal response as those participants who received placebo. They further achieved a 50% reduction in UPCR 2 times as quickly as those who received standard of care only.
“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, MD, professor of medicine and the director of the division of nephrology at Ohio State University Wexler Medical Center, and AURORA clinical trial investigator in a news release issued by Aurinia Pharmaceuticals, which manufactures voclosporin. “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.”
FDA approves Aurinia Pharmaceuticals’ LUPKYNIS™ (voclosporin) for adult patients with active lupus nephritis. News release. January 22, 2021. Accessed February 1, 2021. https://ir.auriniapharma.com/press-releases/detail/210/fda-approves-aurinia-pharmaceuticals-lupkynis