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                                    <figcaption>Voyxact inhibits APRIL, a key factor in IgA nephropathy, reducing serum pathogenic Gd-IgA1 levels implicated in its development. Credit: sasirin pamai/Shutterstock.com.</figcaption>
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<p>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.</p>



<p>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.</p><div>
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<p>It is the first therapy designed to block A-proliferation-inducing ligand (APRIL).</p><div id="slot-one"></div><div id="Sgpollsputhere"></div>



<p>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.</p>



<p>The long-term effect of Voyxact on kidney function decline in IgAN is yet to be established.</p>



<p>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.</p><div> 
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<p>Otsuka 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.</p>



<p>“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.”</p><div id="slot-two"></div>



<p>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.</p>



<p>VISIONARY is a placebo-controlled, global, randomised, double-blind study of 510 adults with IgAN on standard supportive therapy.</p>



<p>In May 2025, the US FDA accepted Otsuka Pharmaceutical’s biologics licence application for sibeprenlimab for review.</p>
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OTSKY

<p>Otsuka Pharmaceutical has received accelerated FDA approval for Voyxact (sibeprenlimab-szsi), a therapy for reducing proteinuria in adults with primary IgA nephropathy (IgAN) at risk of disease progression. Voyxact, administered subcutaneously every four weeks, showed a 51% placebo-adjusted reduction in proteinuria in a Phase III trial. The approval is based on proteinuria reduction as a surrogate marker, with long-term effects on kidney function still under study. Continued approval depends on further trial results expected in 2026.</p>

FDA grants accelerated approval for Otsuka’s IgAN therapy