Sibeprenlimab's priority review highlights potential to differentiate in IgAN space

Sibeprenlimab's priority review highlights potential to differentiate in IgAN space - Express Pharma

Otsuka Pharmaceutical recently announced that the FDA has accepted for review the Biologics License Application (BLA) for sibeprenlimab, which acts as A Proliferation Inducing Ligand (APRIL) inhibitor in development for immunoglobulin A (IgA) nephropathy (IgAN). This followed sibeprenlimab’s 2024 FDA breakthrough designation for the same indication. The BLA was supported by the Phase III VISIONARY trial data. If approved, sibeprenlimab could pro…

Sibeprenlimab's priority review highlights potential to differentiate in IgAN space, says GlobalData - GlobalData

Otsuka Pharmaceutical recently announced that the FDA has accepted for review the Biologics License Application (BLA) for sibeprenlimab, which acts as A Proliferation Inducing Ligand (APRIL) inhibitor in development for immunoglobulin A (IgA) nephropathy (IgAN). This followed sibeprenlimab’s 2024 FDA breakthrough designation for the same indication. The BLA was supported by the Phase III VISIONARY trial data. If approved, sibeprenlimab could pro…

Sibeprenlimab's priority review highlights potential to differentiate in IgAN space

Sibeprenlimab acts as an a proliferation-inducing ligand (APRIL) inhibitor in development for immunoglobulin A (IgA) nephropathy (IgAN).The post Sibeprenlimab’s priority review highlights potential to differentiate in IgAN space appeared first on Clinical Trials Arena.