PRINCETON, N.J. & TOKYO — Otsuka Pharmaceutical announced that the U.S. Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) for sibeprenlimab, a monoclonal antibody therapy for the treatment of immunoglobulin A nephropathy (IgAN). The application has been granted priority review, with a Prescription Drug User Fee Act (PDUFA) target action date set for November 28, 2025.
If approved, sibeprenlimab would offer patients a convenient self-administered treatment option delivered via a prefilled syringe for subcutaneous injection once every four weeks. This would mark a significant development for patients with IgAN, a progressive and chronic autoimmune kidney disease that often leads to end-stage kidney disease (ESKD).
Sibeprenlimab works by selectively inhibiting APRIL (A PRoliferation-Inducing Ligand), a protein that plays a central role in the disease’s underlying mechanism. In IgAN, pathogenic galactose-deficient IgA1 (Gd-IgA1) triggers the production of harmful autoantibodies and immune complex formation, which accumulate in the kidneys and contribute to progressive damage.
The BLA submission is supported by data from the ongoing Phase 3 VISIONARY trial and the earlier Phase 2 ENVISION trial. In the VISIONARY trial, sibeprenlimab met its primary endpoint at a prespecified interim analysis, demonstrating a statistically significant and clinically meaningful reduction in 24-hour urine protein-to-creatinine ratio (uPCR) after nine months of treatment compared to placebo.
“Sibeprenlimab has the potential to be a meaningful advance in the treatment of IgA nephropathy,” said Dr. John Kraus, Executive Vice President and Chief Medical Officer of Otsuka Pharmaceutical Development & Commercialization, Inc. “If approved, it would provide patients with the convenience of monthly self-injections while delivering clinical benefit. This reflects our long-standing commitment to developing treatments for complex and underserved conditions in nephrology.”
Sibeprenlimab has already received Breakthrough Therapy designation from the FDA, based on positive Phase 2 results. The drug targets the upstream biology of IgAN through APRIL inhibition, aiming to reduce immune complex formation and delay or prevent progression to ESKD.
IgA nephropathy remains a significant unmet medical need, with many patients facing a lifetime risk of kidney failure despite current standard-of-care treatments. Otsuka’s sibeprenlimab may represent a new therapeutic strategy for addressing the root cause of this debilitating disease.
