Otsuka reported positive results from the Phase 3 VISIONARY trial, showing that sibeprenlimab (VOYXACT) stabilized kidney function and reduced progression to kidney failure in patients with IgA nephropathy (IgAN) over two years.
The global, randomized, placebo-controlled study met its key secondary endpoint, demonstrating statistically significant effects on estimated glomerular filtration rate (eGFR), including both annualized slope and mean change from baseline at 24 months. The findings indicate a slowing of kidney function decline, with evidence of improvement compared to placebo.
According to the company, the results align with treatment goals outlined in the 2025 KDIGO guidelines, which emphasize reducing kidney function decline to near physiological levels. The therapy was also reported to be well tolerated, with a safety profile comparable to placebo.
Sibeprenlimab targets A Proliferation-Inducing Ligand (APRIL), a pathway involved in the production of pathogenic immunoglobulin A. The mechanism is intended to reduce disease-driving immune activity without broad B-cell depletion.
The VISIONARY study previously supported the drug’s accelerated approval by the U.S. Food and Drug Administration in November 2025 based on reductions in proteinuria at nine months. The newly reported two-year eGFR data are expected to support a supplemental biologics license application seeking traditional approval.
IgA nephropathy is a chronic, immune-mediated kidney disease that can lead to progressive loss of renal function and eventual kidney failure.
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