The U.S. Food and Drug governance (FDA) approved sibeprenlimab-tnls for the treatment of immunoglobulin A nephropathy (IgAN) on November 26, 2025, marking the first targeted therapy for the chronic kidney disease. The approval offers a new treatment option for an estimated 125,000 people in the United States living with IgAN, a leading cause of glomerulonephritis and end-stage renal disease.
IgAN causes a buildup of immunoglobulin A protein in the kidneys, leading to inflammation and progressive damage. Until now, treatment has focused on managing symptoms and slowing disease progression, primarily through blood pressure control and immunosuppressants. Sibeprenlimab, a monoclonal antibody, selectively targets and blocks the neonatal Fc receptor (FcRn), reducing circulating levels of IgA and thereby lessening kidney inflammation. This approval represents a importent advancement in the treatment of IgAN, perhaps delaying or preventing the need for dialysis or kidney transplantation.
The FDA granted sibeprenlimab breakthrough therapy designation, and accepted the Biologics License Submission (BLA) for priority review. The approval is supported by data from a Phase 2 clinical trial published in the New England Journal of Medicine in 2024, led by Mathur M, Barratt J, Chacko B, et al., demonstrating significant reductions in proteinuria-a key marker of kidney damage-in patients treated with sibeprenlimab.
According to Otsuka Pharmaceutical, the company developing sibeprenlimab, the drug received U.S. FDA breakthrough therapy designation for the treatment of IgAN on February 16, 2024. The drug’s efficacy and safety profile will continue to be monitored as it becomes available to patients.
