The FDA granted accelerated approval to Otsuka Pharmaceutical’s sibeprenlimab (Voyxact) to reduce proteinuria in adults with primary IgA nephropathy (IgAN). The decision follows a multicenter, randomized, double-blind phase III Visionary trial whose nine‑month interim analysis showed a statistically significant reduction in 24‑hour urine protein‑to‑creatinine ratio versus placebo. Otsuka reported consistent treatment effects across subgroups and a safety profile comparable to placebo in the 150‑patient safety set; the company plans ongoing follow‑up as the pivotal study continues. The approval establishes the first therapy targeting APRIL, a B‑cell cytokine implicated in IgAN pathogenesis, and adds a novel mechanism to an active clinical landscape that includes APRIL/BAFF dual inhibitors. Clinicians and payors will closely watch longer‑term eGFR and remission data now being collected; regulators required confirmatory evidence post‑approval, and the label reflects a need for continued outcome monitoring.