The Food and Drug Administration (FDA) has approved Lupkynis™ (voclosporin; Aurinia Pharmaceuticals) in combination with a background immunosuppressive therapy regimen to treat adult patients with active lupus nephritis.
Voclosporin, a calcineurin inhibitor, works by blocking interleukin (IL)-2 expression and T-cell mediated immune responses and stabilizing the podocyte in the kidney. The approval was based on data from the pivotal phase 3 AURORA and phase 2 AURA-LV studies. The 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 AURORA study was renal response, defined as urinary protein-to-creatinine ratio (UPCR) less than or equal to 0.5mg/mg, estimated glomerular filtration rate [eGFR] greater than or equal to 60mL/min/1.73m2, or no confirmed decrease from baseline in eGFR greater than 20%, presence of sustained, low dose steroids and no administration of rescue medication.
Results 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: 2.7; 95% CI, 1.6-4.3; P <.001). Additionally, a higher proportion of patients treated with voclosporin achieved complete renal response at week 24 compared with placebo (32.4% vs 19.7%; odds ratio: 2.2; 95% CI, 1.3-3.7). Time to UPCR of less than or equal to 0.5mg/mg was also observed to be shorter in the voclosporin arm compared with placebo (median time of 169 days vs 372 days; hazard ratio: 2.0; [95% CI, 1.5-2.7]).
The most common adverse reactions (incidence of greater than or equal to 3%) reported with voclosporin were decreased GFR, hypertension, diarrhea, headache, anemia, cough, UTI, abdominal pain upper, dyspepsia, alopecia, renal impairment, abdominal pain, mouth ulceration, fatigue, tremor, acute kidney injury, and decreased appetite.
Lupkynis carries a Boxed Warning regarding an increased risk for developing malignancies and serious infections which may lead to hospitalization or death. The safety and efficacy of Lupkynis have not been established beyond 1 year of treatment or in combination with cyclophosphamide.
Lupkynis is supplied as 7.9mg capsules of voclosporin in 60-count and 180-count wallets. To assist patients and health care providers, the Company has launched the Aurinia Alliance, which provides educational resources, financial assistance information, and other tools.
1. FDA approves Aurinia Pharmaceuticals’ Lupkynis™ (voclosporin) for adult patients with active lupus nephritis. [press release]. Victoria, British Columbia and Rockville, MD: Aurinia Pharmaceuticals; January 22, 2021.
2. Lupkynis [package insert]. Rockville, MD; Aurinia Pharma US; 2021.