FDA Approves Voclosporin Label Update in Lupus Nephritis to Reflect Long-Term Data


FDA approves label update for voclosporin (Lupkynis) in lupus nephritis, reflecting long-term AURORA data and new kidney function monitoring guidance.

US FDA logo in black over a white background. | Credit: US Food and Drug Administration

Credit: US Food and Drug Administration

The US Food and Drug Administration has approved a label update for voclosporin (Lupkynis), which is approved for use combination with a background immunosuppressive therapy regimen to treat adult patients with active lupus nephritis, to now reflect long-term data from the AURORA program.

Announced by Aurinia on April 30, 2024, the approved label update comes more than 3 years after voclosporin became the first FDA-approved oral therapy for lupus nephritis in January 2021. Based on data from the AURORA clinical program, the updated label will no longer include language indicating that the safety and efficacy had not been established beyond 1 year and will include 3-year data from the AURORA 2 study, which assessed the long-term safety and tolerability in combination with mycophenolate mofetil (MMF) and low-dose glucocorticoids, compared with MMF and low-dose glucocorticoids alone, in adults who completed the phase 3 AURORA 1 clinical trial.

“Data from our AURORA 2 extension study included in the LUPKYNIS label showed a maintenance of sustained complete renal response with LUPKYNIS in combination with MMF and low-dose glucocorticoids, at every time point assessed through three years, relative to MMF and low-dose glucocorticoids alone,” said Greg Keenan, MD, chief medical officer of Aurinia. “This notable outcome is aligned with treatment guidelines calling for use of LUPKYNIS for at least three years to reduce proteinuria.”

In addition to the label reflecting the presence of long-term data for voclosporin, the updates label will also include new guidance for monitoring kidney function in patients receiving voclosporin, with the new guidance advocating for eGFR assessment every two weeks for the first month of treatment, every 4 weeks through the first year, and quarterly thereafter. The label also provides updated lactation data on the transfer of voclosporin to breast milk based on a twice-daily dosing regimen.

The initial approval of voclosporin in 2021, which occurred under Priority Review and a Fast Track designation from the agency from 2016, was based on data from the phase 3 AURORA 1 trial and the AURA-LV phase 2 study. The phase 3 AURORA 1 trial was a double-blind, multicenter, placebo-controlled comparing oral voclosporin (23.7 mg twice daily) against placebo, in addition to MMF and rapidly tapered low-dose oral steroids, among patients with a diagnosis of systemic lupus erythematosus with lupus nephritis according to the American College of Rheumatology criteria, and a kidney biopsy within 2 years that showed class III, IV, or V.

Conducted in 142 sites across 27 countries, the trial was designed with a primary endpoint of complete renal response at 52 weeks defined as a composite of urine protein creatinine ratio of 0.5 mg/mg or less, stable renal function, no administration of rescue medication, and no more than 10 mg prednisone equivalent per day for 3 or more consecutive days or for 7 or more days during weeks 44 through 52. Results of the trial suggested patients receiving oral voclosporin were more than twice as likely to achieve renal response and experienced a decline in urine protein creatinine ratio (UPCR) twice as fast as those receiving placebo.

Patients who completed 12 months of treatment in the Phase 3 AURORA 1 study were eligible to enroll in the AURORA 2, which was a double-blind, extension study aimed at assessing the long-term safety and tolerability of voclosporin. The AURORA 2 study included 216 patients.

Results of the trial suggested treatment with voclosporin was well tolerated, with 86.1% completing the study and no unexpected safety signals. Safety analyses revealed the mean corrected estimated eGFR observed was within the normal range and stable in both treatment groups, with an eGFR slope of −0.2 mL/min/1.73 m2 (95% confidence interval [CI] −3.0 to 2.7) in the voclosporin group and −5.4 mL/min/1.73 m2 (95% CI, −8.4 to −2.3) in the placebo group over the 2-year period.

“Overall, this label update provides physicians with important information to treat and manage their [lupus nephritis] patients,” Keenan added.


  1. Aurinia Pharmaceuticals Inc. The U.S. Food & Drug Administration (FDA) approves updated LUPKYNIS® (voclosporin) label to include long-term data from the Aurora Clinical Program. Aurinia Pharmaceuticals Inc. April 30, 2024. Accessed May 1, 2024. https://www.auriniapharma.com/investors-and-media/news-events/press-releases/detail/320/the-u-s-food-drug-administration-fda-approves-updated.
  2. Aurinia Pharmaceuticals Inc. FDA approves Aurinia Pharmaceuticals’ LUPKYNISTM (voclosporin) for adult patients with active lupus nephritis. Aurinia Pharmaceuticals Inc. January 22, 2021. Accessed May 1, 2024. https://www.auriniapharma.com/investors-and-media/news-events/press-releases/detail/210/fda-approves-aurinia-pharmaceuticals-lupkynis.
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