Autoimmune-Summaries: Daily Autoimmune Updates at a Glance
- decodeMR Team
- 3 hours ago
- 1 min read
01/07/2026
Ostuka reported positive Phase 3 results for sibeprenlimab in IgAN (Ref)
Otsuka Pharmaceutical announced positive topline full study results from the Phase 3, VISIONARY/ NCT05248646 trial for VOYXACT® (sibeprenlimab-szsi; Anti-APRIL) in adults with primary IgA nephropathy (IgAN) at risk of disease progression.
Sibeprenlimab demonstrated statistically significant stabilization of eGFR with evidence of improved kidney function versus placebo over 24 months, supporting long-term renal protection in adults with primary IgAN.
VOYXACT received FDA accelerated approval on November 25, 2025 to reduce proteinuria in adults with primary IgAN at risk for disease progression; that approval was based on proteinuria, and long-term kidney-function benefit was not established at the time.
Otsuka began a rolling sBLA submission to the FDA for traditional approval incorporating the 24-month eGFR data.
