FDA Updates Safety & Efficacy Information for Voclosporin

On April 30, the U.S. Food & Drug Administration (FDA) approved a label update for voclosporin (Lupkynis), removing the statement that safety and efficacy had been established only through one year.¹ The label now includes data from a post-marketing study that showed sustained complete renal response in patients after three years of treatment.

Voclosporin has a dual mechanism of action, inhibiting T cell activation and cytokine production, and promoting kidney podocyte stability. The FDA first approved oral voclosporin, a second generation calcineurin inhibitor, for the treatment of adults with active lupus nephritis in combination with a background immunosuppressive therapy in January 2021.² 

Background

The data for this label update were garnered from the AURORA 2 extension study conducted in adults with active lupus nephritis who had completed the phase 3 AURORA 1 clinical trial.

The AURORA 2 clinical trial was placebo controlled and double blind. It assessed the long-term safety and tolerability of voclosporin in patients who received it in combination with mycophenolate mofetil and low-dose glucocorticoids. The control group comprised patients who received only mycophenolate mofetil and low-dose glucocorticoids.³ Study doses were 23.7 mg of voclosporin twice daily or a matched placebo in combination with mycophenolate mofetil (target dose: 2 g daily) and low-dose glucocorticoids (target dose: ≤2.5 mg daily).

Two-hundred and sixteen patients with lupus nephritis from AURORA 1 continued into this extension study. Of these 216 patients, 116 were treated with voclosporin and 100 were in the control group. At the completion of AURORA 2, patients in the voclosporin treatment group (n=90) and those in the control group (n=78) had received 36 months of treatment.

Additional voclosporin label updates include removal of the requirement for a monthly kidney function assessment after the first year of treatment, the addition of new recommendations for kidney function monitoring during the first and subsequent years of treatment, and an unchanged safety profile that is consistent with findings from the AURORA clinical program.

Michele B. Kaufman, PharmD, BCGP, is a freelance medical writer based in New York City and a pharmacist at New York Presbyterian Lower Manhattan Hospital.

References

1. Supplemental approval fulfillment of post-marketing requirement: Lupkynis (voclosporin). U.S. Food & Drug Administration. 2024 Apr 29.
2. New drug application approval letter: Lupkynis (voclosporin). U.S. Food & Drug Administration. 2021 Jan 22.
3. The U.S. Food & Drug Administration (FDA) approves updated Lupkynis (voclosporin) label to include long-term data from the AURORA clinical program [news release]. 2024 Apr 30.