Otsuka’s VOYXACT Shows First IgAN Therapy to Stabilize Kidney Function Decline to Normal Physiologic Levels

Otsuka's appendix to the Phase 3 VISIONARY study demonstrates that VOYXACT (sibeprenlimab-szsi) stabilizes kidney function in patients with immunoglobulin A nephropathy (IgAN) over two years, returning the decline in estimated glomerular filtration rate (eGFR) to a baseline physiologic rate (<1 mL/min/1.73 m²/year) in adults at risk for disease progression.

At the two‑year mark, the annualized eGFR slope on sibeprenlimab was +0.3 mL/min/1.73 m²/year versus −4.2 mL/min/1.73 m²/year on placebo, showing a statistically significant treatment effect of +4.5 mL/min/1.73 m²/year (p<0.0001).

The least‑square mean change from baseline in eGFR was +1.3 mL/min/1.73 m² on VOYXACT versus −7.9 mL/min/1.73 m² on placebo, indicating improvement in kidney function with the drug over placebo.

VOYXACT is the first and only U.S. FDA‑approved selective APRIL inhibitor for IgAN, and the first treatment to demonstrate stabilization of kidney function decline to a physiologic level while showing evidence of improvement, with a safety profile consistent with placebo over two years.

Initial 12‑month data showed that the annualized eGFR slope declined by about 3 points in the treated group versus 7.6 points in the placebo group, and VOYXACT met KDIGO’s therapeutic goal of reducing decline to near‑physiologic levels.