The U.S. Food and Drug Administration granted accelerated approval to sibeprenlimab (Voyxact) to reduce proteinuria in adults with primary IgA nephropathy (IgAN). Otsuka based the filing on interim results from the Phase III Visionary trial showing large, clinically meaningful reductions in 24‑hour urine protein-to-creatinine ratio at nine and 12 months versus placebo and a favorable safety profile. Voyxact is the first approved therapeutic that specifically targets APRIL, a cytokine involved in IgAN pathogenesis; APRIL inhibition reduces production of pathogenic immunoglobulins and proteinuria. The approval is conditional on longer-term kidney‑function data (eGFR) due from ongoing follow-up.
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