Otsuka Pharmaceutical Development & Commercialization, Inc. and Otsuka Pharmaceutical Co., Ltd. announced that the US FDA has granted accelerated approval for Voyxact (sibeprenlimab-szsi) to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk of disease progression. Voyxact is a self-administered subcutaneous injection given once every four weeks and is the first therapy to block APRIL (A-Proliferation-Inducing Ligand).

The approval is based on interim results from the Phase 3 VISIONARY trial, where Voyxact demonstrated a 51% placebo-adjusted reduction in proteinuria at nine months (–50% vs 2%), a clinically meaningful improvement as proteinuria reduction is a well-established surrogate marker linked to delaying kidney failure.

As the approval was granted under the accelerated pathway, continued authorization will depend on confirmatory evidence showing long-term clinical benefit. Data from the ongoing VISIONARY Phase 3 trial, assessing the effect of Voyxact on eGFR decline over 24 months, are expected in 2026 and intended to support traditional FDA approval.

Otsuka highlighted Voyxact as a targeted therapy designed to address the underlying drivers of IgAN by blocking APRIL, a key factor in producing pathogenic galactose-deficient IgA1 (Gd-IgA1). Investigators and patient advocacy groups welcomed the approval as an important advancement for patients with limited treatment options.

In the VISIONARY interim analysis of 320 patients, the most common adverse reactions with Voyxact were infections (49%) and injection-site reactions (24%), mostly mild to moderate. The full VISIONARY study includes 510 adult patients on standard-of-care therapy and continues to evaluate both efficacy and long-term kidney outcomes.

IgA nephropathy is a chronic, immune-mediated kidney disease that can lead to end-stage kidney disease over time, with a significant unmet need for therapies that target its root causes.