Otsuka Pharmaceutical Development & Commercialization and Otsuka Pharmaceutical Co. said VOYXACT (sibeprenlimab-szsi) preserved kidney function over 12 months in adults with primary IgA nephropathy at risk for disease progression, based on a pre-specified interim analysis of the ongoing Phase 3 VISIONARY trial. The companies said the data were presented at the European Renal Association Congress 2026 in Glasgow.
In the analysis, patients treated with sibeprenlimab had a mean eGFR change from baseline of +0.7 mL/min/1.73 m², compared with a decline of -4.8 mL/min/1.73 m² in the placebo group, for a treatment effect of 5.5 mL/min/1.73 m². Otsuka also said the annualized eGFR slope was -3.0 mL/min/1.73 m²/year with sibeprenlimab versus -7.6 mL/min/1.73 m²/year with placebo over 12 months.
The company said VOYXACT was generally well tolerated, with infections and injection site reactions the most common adverse events, and that the overall safety profile was comparable to placebo. Otsuka said the findings add to previously observed reductions in Gd-IgA1, proteinuria and hematuria, and it has initiated a rolling submission of a supplemental Biologics License Application to the U.S. FDA for traditional approval based on 24-month eGFR endpoint data.
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