Shots:
- Otsuka Pharmaceutical has reported interim P-III (VISIONARY) trial data evaluating sibeprenlimab (400mg, SC, Q4W) vs PBO in ~510 IgAN pts, who were on SoC therapy
- Trial showed a 51.2% reduction in 24hr. uPCR (1EP) at 9mos. (presented at ERA 2025) & will continue to assess kidney function (2EP) via eGFR over 24mos., with completion expected in early 2026; additional analyses will also be conducted
- Additionally, the US FDA has accepted BLA & granted priority review to sibeprenlimab in May 2025, with PDUFA action date of Nov 28, 2025
Ref: Otsuka Pharmaceutical | Image: Otsuka Pharmaceutical| Press Release
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