Otsuka Holdings Co., Ltd.
Presentation of Final Phase 3 Results for VOYXACT® (sibepremlimab) for IgA Nephropathy at ASN / sBLA Submission to FDA
VOYXACT (sibepremlimab) for IgA nephropathy: final Phase 3 analysis presented at ASN Kidney Week 2026. Demonstrated renal function stabilization and a large reduction in risk of composite renal events (97.1%); safety profile comparable to placebo. sBLA submission to the FDA completed to pursue full approval.
Key Figures
- Reduction in risk of composite renal events over 2 years: 97.1% (sibepremlimab group vs placebo group)
- Reduction in 24-hour urine protein/creatinine ratio (uPCR) at 24 months: 61.3% reduction
- Least squares mean change from baseline in eGFR (at 24 months): sibepremlimab group +1.3 mL/min/1.73 m², placebo group -7.9 mL/min/1.73 m², between-group difference +9.2
- Number of patients initiating renal replacement therapy: sibepremlimab group 0, placebo group 5 cases
- Date of sBLA submission completion for FDA approval: 2026-10-06
AI要約
Progress in New Drug Development
Otsuka Pharmaceutical Group's VOYXACT (sibepremlimab) announced the final analysis results of the VISIONARY Phase 3 trial for IgA nephropathy. Over two years, it reduced the risk of renal function decline and renal failure events by 97.1%, meeting KDIGO 2025 treatment objectives (suppressing annual renal function decline). The safety profile over 24 months was comparable to placebo with no new safety concerns identified.
Regulatory Path and Corporate Value
A supplemental Biologics License Application (sBLA) for VOYXACT has been submitted to the FDA in stages. This represents an important milestone toward obtaining full approval. The development is viewed as a medium- to long-term growth driver and is expected to contribute to enhanced corporate value.
Otsuka Holdings Co., Ltd.
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