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Otsuka Discloses Positive Full Phase 3 Data for Kidney Drug VOYXACT

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Otsuka (TYO:4768) achieved positive full results from the Phase 3 VISIONARY trial evaluating VOYXACT (sibeprenlimab), according to a Tokyo bourse filing on Thursday.

The first APRIL inhibitor to show statistically significant stabilization of eGFR with evidence of improvement over two years in IgA nephropathy patients targets APRIL, a cytokine that drives B-cell survival and the overproduction of harmful autoantibodies.

The drug also showed robust reductions in progression to kidney failure, with safety consistent with earlier data.

These findings complete the dataset for Otsuka's rolling sBLA submission to the U.S. FDA, following the drug's accelerated approval in November 2025.

Otsuka views VOYXACT as a key growth driver and expects the results to support traditional approval and global marketing applications.

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