The FDA has accepted for priority review the biologics license application (BLA) for sibeprenlimab to treat patients with immunoglobulin A nephropathy (IgAN), a chronic kidney disease. Regulators have granted the BLA priority review and given sibeprenlimab a Prescription Drug User Fee Act (PDUFA) target action date of Nov. 28, 2025.

If approved, sibeprenlimab would be offered as a prefilled syringe for subcutaneous injection every four weeks, intended for at-home self-administration.

IgAN is a progressive autoimmune condition that can lead to end-stage kidney disease. A recent study has estimated the incidence and prevalence of IgAN in 2021 to be between 198,887 and 208,184 people. But patients with IgAN may be undiagnosed because the disease is asymptomatic and not routinely screened

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