By Fineline Cube 
Japan-based Otsuka Pharmaceutical Co., Ltd. announced the filing of a Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA) for sibeprenlimab, an investigational monoclonal antibody for adults with immunoglobulin A nephropathy (IgAN). This marks a significant step toward making the therapy available in the US.
Drug Mechanism
Sibeprenlimab selectively inhibits the activity of A PRoliferation-Inducing Ligand (APRIL), a key factor in the pathogenesis of IgAN. By targeting APRIL, the drug addresses a critical component of the disease process.
Development Background
Otsuka acquired sibeprenlimab through its USD 430 million acquisition of US-based Visterra, Inc. in 2018, along with other investigational assets for kidney diseases.
Clinical Trial Success
The BLA is supported by positive results from the Phase II ENVISION study (NCT04287985) and the Phase III VISIONARY study (NCT05248646). These trials demonstrated that sibeprenlimab significantly reduced the 24-hour urinary protein creatinine ratio (uPCR) compared to placebo and showed favorable safety and tolerability.
Regulatory Recognition
Sibeprenlimab received Breakthrough Therapy Designation from the FDA based on the promising results from the ENVISION study, underscoring its potential to address significant unmet medical needs in IgAN patients.-Fineline Info & Tech