FDA accepts sibeprenlimab BLA for priority review

Japanese drugmaker Otsuka Pharmaceutical (TYO: 4578) today announced the US Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for sibeprenlimab, an investigational monoclonal antibody that selectively inhibits the activity of APRIL (A PRoliferation-Inducing Ligand) in adults with immunoglobulin A nephropathy (IgAN). Otsuka’s shares rose 3.1% to 6,854 yen on the news.

APRIL plays a key role in the pathogenesis of IgAN as explained by the 4-hit process, in which pathogenic galactose-deficient IgA (Gd-IgA1) is produced, leading to the synthesis of autoantibodies against Gd-IgA1, immune complex formation, and deposition in the glomerular mesangium. Sibeprenlimab is a single-dose prefilled syringe for subcutaneous injection every four weeks intended for self-administration, providing patients the convenience of at-home delivery.

The BLA is supported by the Phase III VISIONARY clinical trial (NCT05248646), which met its primary endpoint at the prespecified interim analysis, and results from the Phase II ENVISION clinical trial (NCT04287985). Sibeprenlimab demonstrated a statistically-significant and clinically-meaningful reduction in 24-hour uPCR after nine months of treatment compared to placebo in the Phase III VISIONARY trial.