Otsuka’s Sibeprenlimab for IgA Nephropathy Granted FDA Priority Review
Tuesday, May 27, 2025
Otsuka Pharmaceutical have announced that the US Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for sibeprenlimab for priority review.
Sibeprenlimab has already received Breakthrough Therapy designation from the FDA, supported by favourable outcomes from the Phase 2 trial. The therapy is intended to help reduce Gd-IgA1 levels, which are central to the formation of harmful immune complexes. By lowering these levels and inhibiting APRIL, sibeprenlimab may help to limit immune-mediated kidney damage and slow disease progression.
IgAN primarily affects adults between the ages of 20 and 40. It is a long-term disease that gradually leads to end-stage kidney disease (ESKD) in many patients, often requiring dialysis or transplantation. Existing treatments mainly offer supportive care, and there remains a pressing need for disease-specific therapies that target underlying mechanisms.
APRIL is part of the tumour necrosis factor (TNF) family and plays a key role in supporting B-cell function and IgA production, particularly Gd-IgA1. Inhibiting APRIL could therefore help disrupt the disease pathway in IgAN and improve long-term outcomes for affected individuals.
The investigational therapy is intended for the treatment of immunoglobulin A nephropathy (IgAN), a progressive autoimmune kidney disease.
Sibeprenlimab is a monoclonal antibody designed to target and inhibit APRIL (A Proliferation-Inducing Ligand), a cytokine involved in the disease’s development. IgAN is driven by a process known as the "4-hit" model, where abnormal IgA (galactose-deficient IgA1 or Gd-IgA1) is produced and leads to immune complex formation. These complexes build up in the kidneys, resulting in inflammation and eventual loss of kidney function.
The treatment is formulated for subcutaneous self-administration once every four weeks using a single-dose prefilled syringe, offering patients greater flexibility and convenience.
With the FDA granting priority review, the Prescription Drug User Fee Act (PDUFA) date has been set for 28 November 2025.
Source: otsuka.co.jp
