Shots:
- The US FDA has granted accelerated approval to Voyxact (sibeprenlimab-szsi) for the reduction of proteinuria in adults with primary IgAN at risk for disease progression
- Approval was based on the interim data from the ongoing P-III (VISIONARY) trial, assessing Voyxact (400mg, SC, Q4W) vs PBO in 510 IgAN adults, who were on SoC therapy
- Trial met its 1EP, showing a PBO-adjusted 51% reduction in proteinuria at 9mos. (n=320), with eGFR decline data expected in early 2026 & it will support traditional FDA approval
Ref: Otsuka Pharmaceutical | Image: Otsuka Pharmaceutical | Press Release
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