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Otsuka's VOYXACT Halts Kidney Function Decline in Phase 3 Trial

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Otsuka Holdings (TYO:4578) said new two-year data from its Phase 3 Visionary trial showed that VOYXACT effectively stopped kidney function decline in patients with IgA nephropathy (IgAN), a progressive kidney disease.

Patients treated with VOYXACT maintained stable kidney function at near-normal levels, while those on placebo continued to experience significant deterioration, according to a Tokyo bourse filing on Tuesday.

The drug demonstrated a strong safety profile over two years, with no new safety concerns and even lower rates of serious infections compared to the placebo group.

These results complete the Phase 3 study and support Otsuka's ongoing application to the U.S. FDA for full traditional approval of VOYXACT.

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