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FDA Approval of Sibeprenlimab Signals New Era in IgA Nephropathy: Jackson Peter Kim, MD

The FDA granted accelerated approval to sibeprenlimab‑szsi (Voyxact) for primary IgA nephropathy, marking the first APRIL‑inhibiting monoclonal antibody for this condition. Interim results from the phase 3 VISIONARY trial showed a 50 % reduction in proteinuria at nine months versus 2 % with placebo, while safety was comparable to standard care. The drug is administered as a 400‑mg subcutaneous injection every four weeks and targets B‑cell maturation to lower pathogenic IgA. Experts view the approval as a pivotal expansion of therapeutic options beyond supportive care and steroids.