The U.S. Food and Drug Administration has approved a significant update to the label of LUPKYNIS, enhancing its usability and effectiveness in treating lupus nephritis with new long-term data and reduced monitoring requirements.
The U.S. Food and Drug Administration (FDA) has recently approved a significant label update for LUPKYNIS® (voclosporin), enhancing the treatment landscape for patients with active lupus nephritis (LN). This update incorporates three-year data from the AURORA 2 clinical extension study, providing robust long-term efficacy and safety information.
Lupus nephritis is one of the most severe consequences of systemic lupus erythematosus (SLE), a chronic autoimmune disease. The condition primarily affects the kidneys, potentially leading to kidney failure and other serious health complications. Historically, the management of LN has been challenging, with a need for therapies that can sustain renal response without undue side effects.
The recent label update for LUPKYNIS now includes findings from the AURORA clinical program, which demonstrate that the drug, in combination with mycophenolate mofetil (MMF) and low-dose glucocorticoids, sustains complete renal response over three years. This is a significant extension from the initial one-year efficacy data. The results indicate that 20.1% of patients administered LUPKYNIS achieved sustained complete renal response, contrasted with 11.8% on placebo.
An important element of this update is the modification of monitoring requirements for kidney function. Initially, patients on LUPKYNIS needed monthly assessments of estimated glomerular filtration rate (eGFR) throughout the treatment duration. With the new guidelines, after the first year, these assessments will only be necessary quarterly. This change not only aligns better with routine clinical practice but also reduces the treatment burden on patients.
Dr. Greg Keenan, Chief Medical Officer of Aurinia Pharmaceuticals Inc., noted that this update reflects real-world clinical practice and supports the extended use of LUPKYNIS in managing LN. The safety profile of LUPKYNIS remains consistent with earlier findings from the AURORA studies, which is reassuring for healthcare providers and patients.
The update also enriches the data available on LUPKYNIS during lactation. Given that lupus predominantly affects women, often during childbearing years, this information is vital to help inform decisions about breastfeeding during treatment.
LUPKYNIS first received FDA approval in January 2021 as the inaugural oral treatment dedicated to LN. It works by inhibiting T-cell activation and cytokine production while promoting podocyte stability in the kidneys—critical actions for tackling the underlying mechanisms of LN.
The ongoing evolution of the treatment guidelines and prescribing information for LUPKYNIS is not just a regulatory matter but marks a significant stride forward in the therapeutic management of lupus nephritis. The extension of efficacy data to three years provides clinicians and patients with a greater breadth of evidence to support the use of LUPKYNIS in long-term treatment plans, aiming at improving outcomes for patients grappling with this challenging autoimmune disease.
Aurinia Pharmaceuticals continues to focus on autoimmune conditions with a robust commitment to addressing unmet medical needs, as evidenced by their detailed involvement in the development and comprehensive study of voclosporin across multiple treatment horizons.
