The U.S. FDA granted accelerated approval to Otsuka’s sibeprenlimab (Voyxact) for adults with primary IgA nephropathy to reduce proteinuria. Approval was supported by interim results from the phase III Visionary trial showing a ~51% reduction in 24‑hour urine protein‑to‑creatinine ratio at nine months versus placebo and a favorable safety profile. Otsuka plans self‑administered subcutaneous dosing every four weeks; longer‑term eGFR data and ongoing studies will inform full approval and market positioning.