Otsuka Holdings Announces Positive Phase 3 Data for VOYXACT in IgA Nephropathy

TOKYO, Aug 04 (Pulse News Wire) – Otsuka Holdings CO.,LTD. (4578.T) announced positive data from the Phase 3 VISIONARY trial for VOYXACT (sibeprenlimab) in adult patients with IgA nephropathy.

Over two years, VOYXACT demonstrated a significant improvement in estimated glomerular filtration rate (eGFR) compared to placebo, stabilizing kidney function within normal aging ranges. The study showed VOYXACT reduced the annual decline in eGFR slope by 4.5 mL/min/1.73 m²/year versus placebo. Additionally, VOYXACT maintained a favorable safety profile throughout the two-year period.

Dr. Dana Rizk, principal investigator and co-chair of the Visionary Trial Steering Committee, noted that achieving physiological levels of renal function decline aligns with international treatment goals and offers hope for improved long-term outcomes for patients with progressive disease. John Kraus, Senior Vice President and Chief Medical Officer at OPDC, emphasized the significance of these findings, which support VOYXACT's potential as a disease-modifying therapy for IgA nephropathy.

The results further strengthen the application for traditional approval by the US FDA and will inform regulatory submissions globally.