The FDA granted accelerated approval to Otsuka’s sibeprenlimab (anti-APRIL) for immunoglobulin A nephropathy (IgAN), marking the first approval for a therapy that directly targets APRIL-mediated B‑cell activity in this disease. The decision broadens treatment options for nephrologists managing progressive IgAN and introduces a targeted biologic into a space long dominated by supportive care. Regulatory documents and company statements indicate the approval was supported by clinical data demonstrating meaningful reductions in proteinuria and signals of renal stabilization. Otsuka highlighted the therapy as a new mechanism for slowing IgAN progression and said it will work with payors and clinicians to integrate the drug into practice. Nephrology clinics and diagnostic labs should expect demand for patient identification and biomarker-driven enrollment strategies. Payers will likely scrutinize real-world effectiveness and safety as the company moves from accelerated approval toward confirmatory evidence.