Otsuka presents long-term Phase 3 data for Voyxact, aiming to secure full FDA approval for kidney disease

Otsuka announced new long-term results from the Phase 3 trial of its kidney disease drug Voyxact.

The data show that the therapy stabilized kidney function over an extended period, building on earlier findings that supported its accelerated approval.

Company officials said the results are a key step toward converting the conditional approval into a full, permanent endorsement by regulators.

If the FDA accepts the data, Voyxact could become the first therapy with this indication to receive full approval, potentially expanding its market.