The U.S. FDA granted accelerated approval to Otsuka’s sibeprenlimab (Voyxact) for adults with primary IgA nephropathy (IgAN), marking the first approval of an APRIL‑blocking monoclonal antibody in this indication. The approval was supported by interim results from the Phase III Visionary trial showing a statistically significant reduction in 24‑hour urine protein-to-creatinine ratio at nine months and sustained benefit at a 12‑month interim readout. Otsuka positioned Voyxact as a self‑administered subcutaneous therapy dosed every four weeks. Clinical data presented showed reductions in serum immunoglobulins, APRIL, galactose‑deficient IgA1 and higher rates of proteinuric remission versus placebo, with a safety profile consistent with prior findings. The company obtained a priority review and plans broader commercialization while ongoing studies continue to collect eGFR outcomes at 24 months. Regulatory and market commentary emphasized that Voyxact could reshape treatment pathways for IgAN and that other APRIL‑targeting programs may follow, underscoring competition and market opportunity in a disease with significant unmet need.