Accelerated FDA approval for Otsuka’s Voyxact

The US Food and Drug Administration (FDA) has granted accelerated approval of Voyxact (sibeprenlimab-szsi) for the reduction of proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk for disease progression.

The drug, which was developed by Japanese drugmaker Otsuka (TYO: 4578), is a self-administered, subcutaneous injection dosed every four weeks. The news pushed the company’s shares up 4.2% to 9,027 yen by close of trading today.

Voyxact was granted accelerated approval based on the VISIONARY Phase III interim analysis, where it achieved a significant placebo-adjusted treatment effect of 51% (P<0.0001) reduction in proteinuria at nine months (n=320) of treatment (50% VOYXACT vs 2% placebo). Voyxact is the first and only therapy to block A-PRoliferation-Inducing-Ligand (APRIL).