The U.S. Food and Drug Administration (FDA) has approved Voyxact (sibeprenlimab) for the reduction of proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk for disease progression.
IgAN is a kidney disorder that occurs when IgA protein accumulates in the kidneys. In the early stages, IgA nephropathy has no symptoms. The first sign of this condition may be blood in the urine. End-stage kidney disease may develop. In most instances, the cause of this condition is unknown; however, certain disorders have been linked with IgA nephropathy, such as cirrhosis of the liver, celiac disease, and HIV infection.
Sibeprenlimab is a humanized monoclonal antibody that binds to and blocks APRIL, which plays a key role in the 4-hit process of IgAN pathogenesis and is an important initiating and sustaining factor in IgAN progression by promoting the production of pathogenic galactose-deficient IgA1. Inhibition of APRIL results in reduced levels of serum galactose-deficient IgA1 (Gd-IgA1), which is implicated in the pathogenesis of IgAN.
The approval is based on data from the multicenter, randomized, double-blind, placebo-controlled phase 3 VISIONARY clinical trial. The trial enrolled 510 adult patients with IgAN who were on standard-of-care therapy and evaluated the safety and efficacy of sibeprenlimab compared to placebo.
Results illustrated a 51% reduction in proteinuria at nine months of treatment with sibeprenlimab versus 2% in placebo. The study is ongoing and data on the annualized slope of estimated glomerular filtration rates over 24 months is expected to be available early 2026.
The most common adverse reactions in patients treated with sibeprenlimab were infections and injection site reactions. Most adverse reactions were mild or moderate in severity and resolved without interruption or discontinuation of treatment.
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To learn more about IgAN and other rare kidney diseases, visit https://checkrare.com/diseases/kidney-and-urinary-diseases/