Posted by Michael Wonder on 31 Mar 2025
Otsuka files biologics license application for sibeprenlimab in the treatment of immunoglobulin A nephropathy
31 March 2025 - Otsuka today announce the filing of a biologics license application with the US FDA for sibeprenlimab, an investigational monoclonal antibody that selectively inhibits the activity of APRIL (A PRoliferation-Inducing Ligand) in adults with immunoglobulin A nephropathy.
The biologics license application submission, Otsuka’s first, is supported by results from the Phase 2 ENVISION clinical trial and the Phase 3 VISIONARY clinical trial, which met its primary endpoint by demonstrating that sibeprenlimab produced a statistically significant and clinically meaningful reduction in 24-hour uPCR (urine protein-to-creatine ratio) compared to placebo after nine months of treatment.
