Otsuka Pharmaceutical has secured accelerated approval from the US Food and Drug Administration (FDA) for Voyxact (sibeprenlimab-szsi) to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at disease progression risk.
Voyxact is administered as a self-injected subcutaneous dose every four weeks. Its approval was based on the interim results of the Phase III VISIONARY trial, which demonstrated a 51% placebo-adjusted reduction in proteinuria at nine months in 320 participants.
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It is the first therapy designed to block A-proliferation-inducing ligand (APRIL).
Proteinuria reduction serves as a surrogate marker linked to delayed progression to kidney failure. The FDA approval was granted under the accelerated pathway based on this marker.
The long-term effect of Voyxact on kidney function decline in IgAN is yet to be established.
Continued approval depends on confirmation from the ongoing VISIONARY Phase III study, which evaluates disease progression through estimated glomerular filtration rate (eGFR) reduction at 24 months, with data anticipated in early 2026.
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By GlobalDataOtsuka executive vice-president and chief medical officer John Kraus stated: “The availability of Voyxact represents a novel targeted approach to help manage this complex disease for patients living with IgAN.
“With its targeted mechanism, strong efficacy, safety profile and once-every-four-weeks dosing, Voyxact offers a new option for IgAN patients. We recognise 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 programme.”
Voyxact inhibits APRIL, a key factor in the four-hit process of IgAN pathogenesis, promoting production of pathogenic galactose-deficient IgA1 (Gd-IgA1). Blocking APRIL reduces serum Gd-IgA1 levels implicated in IgAN development.
VISIONARY is a placebo-controlled, global, randomised, double-blind study of 510 adults with IgAN on standard supportive therapy.
In May 2025, the US FDA accepted Otsuka Pharmaceutical’s biologics licence application for sibeprenlimab for review.
