FDA Grants Accelerated Approval of Voyxact
November 26, 2025
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2 min
7 Key Takeaways
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1
FDA approved Voyxact for IgA nephropathy.
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Significant reduction in proteinuria observed in trial.
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Recommended dose: 400 mg subcutaneously every 4 weeks.
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4
Safety monitoring required for active infections.
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5
Live vaccines should be avoided.
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Common adverse effects include infections and injection site reactions.
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Long-term kidney function effects still under evaluation in VISIONARY trial.
The FDA has granted accelerated approval for Voyxact (sibeprenlimab-szsi) injection aimed at reducing proteinuria in adults with primary immunoglobulin A nephropathy, a condition resulting from abnormal IgA antibody deposits in the kidneys. This disease is typically diagnosed in young adults and can lead to kidney failure. Results from a randomized trial showed a 50% reduction in protein levels in patients using Voyxact at 9 months. Safety protocols emphasize monitoring for infections and avoiding live vaccines prior to and during treatment. Continued approval will depend on further evidence from the ongoing VISIONARY trial regarding its long-term effects on kidney function.
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