{"id":49032,"date":"2025-11-26T15:19:24","date_gmt":"2025-11-26T07:19:24","guid":{"rendered":"https:\/\/flcube.com\/?p=49032"},"modified":"2025-11-26T15:19:25","modified_gmt":"2025-11-26T07:19:25","slug":"otsukas-voyxact-wins-fda-accelerated-approval-for-igan-first-april-blocker","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=49032","title":{"rendered":"Otsuka’s VOYXACT Wins FDA Accelerated Approval for IgAN, First APRIL Blocker"},"content":{"rendered":"\n

Otsuka Pharmaceutical<\/strong> (OTCMKTS: OTSKY<\/a>) announced that VOYXACT (sibeprenlimab\u2011szsi)<\/strong> received U.S. FDA Accelerated Approval<\/strong> for reducing proteinuria in adults with Primary Immunoglobulin A Nephropathy (IgAN)<\/strong> at risk for disease progression, becoming the first and only therapy<\/strong> to block A\u2011PRoliferation\u2011Inducing\u2011Ligand (APRIL)<\/strong> based on VISIONARY Phase\u202fIII interim data showing a 51% placebo\u2011adjusted proteinuria reduction<\/strong> at nine months.<\/p>\n\n\n\n

Regulatory Milestone<\/h2>\n\n\n\n
Item<\/th>Detail<\/th><\/tr><\/thead>
Product<\/strong><\/td>VOYXACT (sibeprenlimab\u2011szsi)<\/td><\/tr>
Company<\/strong><\/td>Otsuka Pharmaceutical<\/td><\/tr>
Developer<\/strong><\/td>Visterra, Inc. (wholly owned subsidiary)<\/td><\/tr>
Agency<\/strong><\/td>U.S. Food and Drug Administration (FDA)<\/td><\/tr>
Approval Type<\/strong><\/td>Accelerated Approval<\/td><\/tr>
Indication<\/strong><\/td>Reduction of proteinuria in adults with primary IgAN at risk for progression<\/td><\/tr>
Study Basis<\/strong><\/td>VISIONARY Phase\u202fIII interim analysis (n=320)<\/td><\/tr>
Key Efficacy<\/strong><\/td>51% placebo\u2011adjusted proteinuria reduction at 9 months (P<0.0001)<\/td><\/tr>
Mechanism<\/strong><\/td>First\u2011in\u2011class APRIL blocker<\/td><\/tr>
Dosing<\/strong><\/td>Subcutaneous injection once every 4 weeks<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

Clinical Evidence \u2013 VISIONARY Study<\/h2>\n\n\n\n
Endpoint<\/th>VOYXACT<\/th>Placebo<\/th>Result<\/th><\/tr><\/thead>
Proteinuria reduction at 9 mo<\/strong><\/td>50%<\/td>2%<\/td>51% placebo\u2011adjusted (P<0.0001)<\/td><\/tr>
Patient population<\/strong><\/td>n=320<\/td><\/td>Significant treatment effect<\/td><\/tr>
Mechanism validation<\/strong><\/td>APRIL blockade reduces Gd\u2011IgA1 production<\/td><\/td>Key pathogenic factor in IgAN<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

Drug Profile<\/h2>\n\n\n\n