The U.S. Food and Drug Administration granted accelerated approval to Otsuka’s anti‑APRIL antibody for IgA nephropathy (IgAN). The agency’s decision opens the first approval in an emerging mechanism aimed at APRIL, a B‑cell survival factor implicated in antibody‑mediated kidney injury. Otsuka framed the approval around sibeprenlimab (Voyxact), citing data that supported reduced disease progression in a high‑need population. Clinicians and nephrology groups will now evaluate how the antibody fits alongside ACE/ARB therapy and SGLT2 inhibitors, and whether payors accept accelerated labeling. The approval creates a new commercial and clinical benchmark for antibody therapies targeting immune drivers of chronic kidney disease. FDA and Otsuka statements were the primary sources for the decision.
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