{"id":36694,"date":"2025-12-02T11:53:14","date_gmt":"2025-12-02T16:53:14","guid":{"rendered":"https:\/\/nephcure.org\/?p=36694"},"modified":"2025-12-02T11:56:32","modified_gmt":"2025-12-02T16:56:32","slug":"the-fda-grants-accelerated-approval-to-voyxact-a-new-treatment-option-for-adults-with-iga-nephropathy","status":"publish","type":"post","link":"https:\/\/nephcure.org\/es\/the-fda-grants-accelerated-approval-to-voyxact-a-new-treatment-option-for-adults-with-iga-nephropathy\/","title":{"rendered":"The FDA Grants Accelerated Approval to VOYXACT, a New Treatment Option for Adults with IgA Nephropathy"},"content":{"rendered":"

December 2, 2025 \u2014 Last week, another major step forward was made for the IgA nephropathy (IgAN) comunidad<\/a>. The FDA granted accelerated approval for VOYXACT (sibeprenlimab-szsi), Otsuka\u2019s new treatment for adults with primary IgAN who are at risk for disease progression.\u00a0<\/p>\n\n\n\n

The FDA\u2019s accelerated approval program allows for earlier access to treatments that address serious conditions with unmet medical needs by using a surrogate endpoint. Defined by\u00a0the FDA, a surrogate endpoint is a clinical trial endpoint used as a substitute for a direct measure of how a patient feels, functions, or survives.\u00a0In this case, the surrogate endpoint is proteinuria reduction.\u00a0<\/p>\n\n\n\n

IgAN<\/a> is a kidney disease in which Immunoglobulin A (IgA) builds up in the kidney. IgA is a protein in the blood and is also part of the immune system. Excess IgA can cause inflammation in the kidney and over time, this leads to scarring in the kidney tissue.\u00a0The severity of kidney disease caused by IgAN varies from person to person. As IgAN progresses, it reduces the kidneys\u2019 ability to filter waste from the blood.<\/p>\n\n\n\n

While VOYXACT is not the first treatment approved for IgAN, it is the\u00a0first therapy<\/strong>\u00a0that blocks a molecule called\u00a0A-PRoliferation-Inducing-Ligand\u00a0(APRIL)<\/strong>.\u00a0APRIL plays a role in creating harmful IgA that drives the disease process.\u00a0By blocking APRIL, VOYXACT reduces levels of galactose-deficient IgA1 (Gd-IgA1), the form of IgA closely linked to IgAN.<\/p>\n\n\n\n

The FDA\u2019s approval for VOYXACT was granted based on interim data from Otsuka\u2019s Phase 3 VISIONARY<\/strong> study, which showed:<\/p>\n\n\n\n