FDA Approves VOYXACT to Treat Kidney Disease

The U.S. 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. 

VOYXACT is a self-administered, subcutaneous injection dosed every four weeks. As the first and only therapy to block A-PRoliferation-Inducing-Ligand (APRIL), it works by blocking APRIL, which plays a key role in the 4-hit process of IgAN pathogenesis and is an important initiating and sustaining factor in IgAN progression by promoting the production of pathogenic galactose-deficient IgA1 (Gd-IgA1). Inhibition of APRIL results in reduced levels of serum Gd-IgA1, which is implicated in the pathogenesis of IgAN.

Approval was based on the VISIONARY Phase III interim analysis, where it achieved a significant placebo-adjusted treatment effect of 51 percent reduction in proteinuria at nine months (n=320) of treatment (-50 percent VOYXACT vs. 2 percent placebo). However, continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory clinical trial from the ongoing Phase III VISIONARY study evaluating whether VOYXACT slows disease progression as measured by estimated glomerular filtration rate (eGFR) decline at 24 months. The eGFR data are expected in early 2026 and are intended to support traditional FDA approval.

“The availability of VOYXACT represents a novel targeted approach to help manage this complex disease for patients living with IgAN,” said John Kraus, MD, PhD, executive vice president and chief medical officer at Otsuka. “With its targeted mechanism, strong efficacy, safety profile and once-every-four-weeks dosing, VOYXACT offers a new option for IgAN patients. We recognize the urgent need for new treatment options for IgAN and are thankful for the patients and healthcare professionals who continue to participate in our clinical trial program.”