The New Drug Application (NDA) for voclosporin (Aurinia Pharmaceuticals) has been submitted to the Food and Drug Administration (FDA) for the treatment for lupus nephritis.
Voclosporin, a novel calcineurin inhibitor, works by blocking interleukin (IL)-2 expression and T-cell mediated immune responses and stabilizing the podocyte in the kidney. The NDA submission includes data from the double-blind, phase 3 AURORA trial that compared the efficacy of voclosporin to placebo when added to standard of care treatment (background mycophenolate mofetil and low-dose corticosteroids) in 357 adult patients with active lupus nephritis. Patients were randomized to receive either voclosporin orally twice daily or placebo for 52 weeks.
Results showed that at 52 weeks, renal response (primary end point) was achieved in 40.8% of voclosporin-treated patients compared with 22.5% of patients in the placebo arm (odds ratio: 2.65; P <.001). Additionally, voclosporin was associated with statistically significant improvements in key secondary end points including renal response at 24 weeks, partial renal response at 24 and 52 weeks, time to achieve urinary protein-to-creatinine ratio (UPCR) ≤0.5mg/mg and time to 50% reduction in UPCR.
Voclosporin was found to be well tolerated, and was not associated with significant decreases in estimated glomerular filtration rate or increases in blood pressure, lipids, or glucose at week 52. The most common serious adverse event reported in the trial was infection (10.1% with voclosporin vs 11.2% in the control arm).
“Our extensive clinical program, including results from both the AURA and AURORA trials, provides strong support for the profile of voclosporin as a novel treatment for lupus nephritis, and we are rapidly advancing our US commercial strategy and infrastructure to support a potential launch early next year,” said Peter Greenleaf, President and Chief Executive Officer of Aurinia.
The NDA submission includes a request for Priority Review, which would shorten the time of the FDA’s review from 12 months to 8 months, if granted.
For more information visit auriniapharma.com.