FDA Grants Accelerated Approval of Voyxact
November 26, 2025
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2 min
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.
1. FDA approved Voyxact for IgA nephropathy. 2. Significant reduction in proteinuria observed in trial. 3. Recommended dose: 400 mg subcutaneously every 4 weeks. 4. Safety monitoring required for active infections. 5. Live vaccines should be avoided. 6. Common adverse effects include infections and injection site reactions. 7. Long-term kidney function effects still under evaluation in VISIONARY trial.
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