The U.S. Food and Drug Administration granted accelerated approval to sibeprenlimab (Voyxact) to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN). Otsuka’s approval was based on the phase III Visionary trial interim analysis showing large, statistically significant reductions in 24‑hour urine protein-to-creatinine ratio at nine months and consistent effects at 12 months presented at ASN Kidney Week. Voyxact is the first approved therapy targeting the cytokine APRIL for IgAN; Otsuka acquired the asset via its 2018 purchase of Visterra. Clinicians and payers will watch ongoing outcome and eGFR data due in 2026; the label and accelerated pathway require continued confirmatory evidence. The approval expands treatment options in a disease with limited targeted therapies and a projected multi-billion-dollar addressable market, and it may accelerate competing APRIL/BAFF programs in late‑stage development. Clarification: APRIL (A proliferation‑inducing ligand) is an immune cytokine that promotes pathological antibody production and kidney inflammation in IgAN.
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