The FDA granted accelerated approval to Otsuka Pharmaceutical’s sibeprenlimab (Voyxact) for adults with primary immunoglobulin A nephropathy (IgAN), based on a phase III Visionary trial interim analysis showing a 51% reduction in 24‑hour urine protein-to-creatinine ratio at nine months versus placebo. The approval was announced ahead of the original PDUFA date and makes Voyxact the first APRIL‑blocking therapy authorized for IgAN. Clinical data presented at Kidney Week and the Visionary trial’s 12‑month interim readout reinforced the benefit: a 56.6% drop in uPCR at 12 months versus a 5.1% increase for placebo. Otsuka positioned the self‑administered subcutaneous antibody as a targeted alternative for proteinuria reduction; the trial reported a safety profile comparable to placebo. Regulators will continue to monitor longer‑term kidney function outcomes (eGFR) in ongoing studies, with full data expected in 2026. For nephrology and specialty biopharma, this approval both validates APRIL as a therapeutic target and signals continued appetite at FDA for accelerated pathways when intermediate biomarkers show robust benefit. The label and pricing dynamics will be watched closely by payers and competing APRIL/BAFF programs.