Otsuka is highlighting new 12‑month kidney‑function data from the Phase 3 VISIONARY trial to support a full approval application for Voyxact (sibeprenlimab) in IgA nephropathy (IgAN).
VOYXACT demonstrated an increase in mean change for estimated glomerular filtration rate (eGFR) from baseline of +0.7 mL/min/1.73 m² compared to a decline of -4.8 mL/min/1.73 m² in the placebo‑treated group over 12 months.
VOYXACT currently has U.S. FDA accelerated approval based on reduction of proteinuria, and continued approval is contingent on confirming clinical benefit in the ongoing VISIONARY trial.
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