Investing.com-- Otsuka Holdings (TYO:4578) shares rose on Wednesday after the company said the U.S. Food and Drug Administration had granted accelerated approval for its kidney drug Voyxact.
Voyxact is a treatment aimed at reducing proteinuria in adults with primary immunoglobulin A nephropathy (IgAN).
The approval was based on an interim analysis of the Phase 3 study, which showed a placebo-adjusted 51% reduction in proteinuria at nine months, according to the company’s press release.
Tokyo-listed Otsuka shares surged as much as 7% to 9,270 yen as of 05:22 GMT.
Otsuka said Voyxact, a subcutaneous injection administered every four weeks, is the first approved therapy that blocks APRIL, a protein implicated in the development of IgAN.
Proteinuria reduction is considered a recognised surrogate marker for slowing progression toward kidney failure, although Otsuka noted that long-term benefits on kidney function have not yet been established.
The FDA’s accelerated approval means continued authorisation will depend on confirmatory data from the ongoing VISIONARY trial, with results on kidney function decline expected in early 2026, the company said.