The FDA granted accelerated approval to Otsuka Pharmaceutical’s sibeprenlimab (Voyxact) to reduce proteinuria in adults with primary IgA nephropathy (IgAN). The decision, announced ahead of the PDUFA date, 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 highlighted consistent effects across subgroups and reported a further 12-month interim readout showing a 56.6% uPCR drop versus 5.1% for placebo. Voyxact is the first APRIL-targeting therapy approved for IgAN and will be administered subcutaneously every four weeks. Regulators granted accelerated approval on the basis of proteinuria reduction; confirmatory data on kidney function (eGFR) are pending from ongoing follow-up. The label and trial design leave room for potential competition from other APRIL/BAFF-targeting programs now in development, and companies and payors will watch full durability and renal-outcome data before wider uptake.