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The U.S. FDA has granted accelerated approval to sibeprenlimab ( Voyxact) for reducing proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk for disease progression.
Sibeprenlimab is the first approved therapy that targets APRIL, a key protein involved in the overproduction of abnormal IgA antibodies that drive IgAN pathogenesis.
It is administered as a 400mg injection once every four weeks, offering a practical and targeted option for long-term disease management.
RemediumOne has been part of the clinical development journey of Sibeprenlimab since its phase 2 study, and continues to support the ongoing open-label extension study. Our team coordinates trial activities across five trial centres in Sri Lanka including:
Sri Jayewardenepura General Hospital
National Hospital of Sri Lanka
Kandy National Hospital
Galle National Hospital
Kurunegala Teaching Hospital
The dedication of our investigators and study team helped generate essential evidence that supported this FDA approval.
The decision was based on the interim results of a global Phase 3 clinical trial that compared sibeprenlimab to a placebo in adults with biopsy-confirmed IgAN.
Key interim-results at 9 months showed:
ā 50% reduction in proteinuria in patients receiving sibeprenlimab
ā 2% increase in proteinuria in the placebo group
ā Strong reduction in APRIL and disease-causing IgA1 levels
ā A safety profile similar to placebo
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