Otsuka Holdings Co., Ltd.
VOYXACT (Sobeprenlimab) IgA nephropathy treatment phase 3 data release
Phase 3 (VISIONARY) trial data for the IgA nephropathy treatment VOYXACT has been disclosed. Demonstrates a significant stabilization of eGFR over 24 months compared with placebo, withSafety profile comparable to placebo. Progress toward FDA sbLA submission in the U.S. continues.
Key Figures
- 24-month eGFR slope: sobeprenlimab group +0.3 (95% CI: −0.4 to 0.9) mL/min/1.73 m²/year
- Placebo group: −4.2 (95% CI: −4.9 to −3.6) mL/min/1.73 m²/year
- Between-group difference: 4.5 (95% CI: 3.6 to 5.4) mL/min/1.73 m²/year
AI要約
Section Heading
Otsuka Holdings Co., Ltd. and its 100% subsidiary Otsuka Pharmaceutical Co., Ltd. disclose the phase 3 (VISIONARY) data for VOYXACT (sobeprenlimab), showing an improvement in the 24-month eGFR slope and achievement of kidney function stabilization. The safety profile is comparable to placebo, and progress toward sBLA submission to the U.S. FDA continues.
Second Section Heading
These data suggest efficacy as a disease-modifying therapy and will support future approval applications and regulatory reviews in various countries. It is positioned as a key milestone that will contribute to medium- to long-term corporate value enhancement.
Otsuka Holdings Corporation
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