Otsuka’s Anti-APRIL Antibody (Voyxact/Sibeprenlimab) Receives FDA Approval for IgA Nephropathy (IgAN)
Otsuka's anti-APRIL antibody, marketed as Voyxact (sibeprenlimab), has received accelerated FDA approval to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk for disease progression1351112.
Voyxact works by selectively inhibiting the protein APRIL (A proliferation-inducing ligand), a central mediator in the pathogenesis of IgAN, thereby reducing the production of pathogenic IgA antibodies2712.
Phase 3 clinical data showed that sibeprenlimab led to a 51.2% reduction in urine protein-to-creatinine ratio (UPCR) compared to placebo, which demonstrates superior efficacy versus leading competitors in the field (e.g., Tarpeyo: 34%, Vanrafia:
38% reduction)2.
The safety profile of sibeprenlimab was favorable, with fewer patients experiencing treatment-emergent adverse events compared to the placebo group in clinical trials2.
The FDA approval comes as additional treatment options for IgAN are entering the market, including Tarpeyo, Fabhalta, Vanrafia, and Filspari, making this a notably crowded and rapidly developing area of kidney disease therapeutics1234.
Voyxact is the first FDA-approved therapy in its class (anti-APRIL mAb) for IgAN, signifying an important advance in targeting the underlying disease process beyond supportive care or general immunosuppressants1312.
Sources:
1. https://www.fiercepharma.com/pharma/ever-more-crowded-kidney-disease-space-otsuka-receives-fda-approval-first-class-voyxact
2. https://www.fiercebiotech.com/biotech/otsukas-kidney-disease-drug-halves-upcr-levels-phase-3-study
3. https://pharmaphorum.com/news/otsuka-joins-igan-market-voxyact-approval-us
4. https://nephcure.org/the-fda-grants-accelerated-approval-to-vanrafia-new-treatment-option-for-adults-with-iga-nephropathy/
5. https://www.statnews.com/2025/11/25/fda-approves-otsuka-kidney-disease-therapy/
7. https://www.otsuka-us.com/news/otsuka-sibeprenlimab-phase-3-data-show-statistically-significant-and-clinically-meaningful
11. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761434s000lbl.pdf