Otsuka Seeks Accelerated Approval for Sibeprenlimab in IgA Nephropathy Following Positive Phase III Interim Results

Positive Interim Results:
Otsuka's Phase III VISIONARY trial for sibeprenlimab, an anti-APRIL monoclonal antibody, has shown statistically significant and clinically meaningful reductions in 24-hour urine protein-to-creatine ratio (uPCR) after nine months in patients with IgA nephropathy (IgAN).

Accelerated Approval Pathway:
Otsuka plans to review the interim data with the FDA to enable a potential regulatory submission for accelerated approval, with final results expected in early 2026.

Breakthrough Therapy Designation:
Sibeprenlimab received Breakthrough Therapy designation from the FDA following positive outcomes from the Phase II ENVISION trial.

Study Design:
The VISIONARY trial is a multicenter, randomized, double-blind, placebo-controlled study enrolling approximately 530 adult patients with IgAN, evaluating the efficacy and safety of sibeprenlimab 400 mg administered subcutaneously every four weeks.

Disease Background:
IgA nephropathy is a progressive, autoimmune, chronic kidney disease that can lead to end-stage kidney disease (ESKD) over the lifetime of most patients under current optimized standard care.