Otsuka's IgAN treatment sibeprenlimab receives FDA priority review

Otsuka Pharmaceutical announced that the FDA has accepted and granted priority review to its Biologics License Application (BLA) for sibeprenlimab, an investigational monoclonal antibody targeting Immunoglobulin A Nephropathy (IgAN). Sibeprenlimab selectively inhibits the activity of APRIL, a key protein in the pathogenesis of IgAN. The BLA submission is supported by Phase 3 VISIONARY clinical trial (NCT05248646) data, which met its primary endpoint, along with results from the Phase 2 ENVISION clinical trial (NCT04287985). The treatment involves subcutaneous injection every four weeks intended for self-administration. The FDA's decision includes a Prescription Drug User Fee Act (PDUFA) target action date of November 28, 2025. If approved, sibeprenlimab would offer a self-injectable option for individuals with IgAN.