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Otsuka Pharmaceutical Receives the US FDA Accelerated Approval for Primary Immunoglobulin A Nephropathy (IgAN)

Shots: The US FDA has granted accelerated approval to Voyxact (sibeprenlimab-szsi) for the reduction of proteinuria in adults with primary IgAN at risk for disease progression Approval was based on the interim data from the ongoing P-III (VISIONARY) trial, assessing Voyxact (400mg, SC, Q4W) vs PBO in 510 IgAN adults, who were on SoC therapy Trial…

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Vera Therapeutics Reports the US FDA’s BLA Submission for Atacicept to Treat IgA Nephropathy

Shots: The US FDA has received the BLA seeking accelerated approval of atacicept for treating adults with immunoglobulin A nephropathy (IgAN), with the FDA’s decision expected in 2026 The BLA is supported by the ongoing global P-III (ORIGIN 3) trial evaluating atacicept (150mg, SC, QW) vs PBO in 431 adults with IgAN, assessing eGFR-based kidney…

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