The Food and Drug Administration (FDA) will give Priority Review to the New Drug Application (NDA) of voclosporin (Aurinia Pharmaceuticals) for the treatment of 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 is supported by data from the pivotal phase 3 AURORA and phase 2 AURA-LV studies.
The pivotal AURORA study compared the efficacy and safety 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. The primary end point of the study was renal response, defined as urinary protein-to-creatinine ratio of ≤0.5mg/mg, estimated glomerular filtration rate [eGFR] ≥60mL/min/1.73m2, or no confirmed decrease from baseline in eGFR of >20%, presence of sustained, low dose steroids and no administration of rescue medication.
Study findings showed that at 52 weeks, renal response 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). As for safety, voclosporin was found to be well tolerated and was not associated with significant decreases in eGFR or increases in blood pressure, lipids, or glucose.
A Prescription Drug User Fee Act (PDUFA) action date of January 22, 2021 has been set for this application. “We will continue to collaborate with the FDA during their review process and in parallel build our commercial readiness for a potential approval and commercial launch in the first quarter of 2021,” said Peter Greenleaf, President and Chief Executive Officer of Aurinia.
For more information visit auriniapharma.com.