The US Food and Drug Administration (FDA) has granted priority review status to Otsuka Pharmaceutical’s biologics license application (BLA) for sibeprenlimab, an investigational monoclonal antibody designed to treat immunoglobulin A nephropathy (IgAN).
With this status, the FDA aims to expedite its evaluation process, setting a Prescription Drug User Fee Act (PDUFA) decision date of 28 November 2025.
Sibeprenlimab targets APRIL, a protein linked to the development of IgAN, and is administered via subcutaneous injection, allowing for patient self-administration.
The BLA submission is supported by data from the Phase 3 VISIONARY trial and the Phase 2 ENVISION trial, both of which showed significant reductions in proteinuria compared to placebo over nine months of treatment.
Otsuka Pharmaceutical Development & Commercialization executive vice president and chief medical officer John Kraus said: “Over the past decade, Otsuka has consistently approached difficult-to-treat diseases in nephrology with scientific and clinical innovation, seeking to provide crucial advancements for underserved patients with complex conditions like IgA nephropathy.
“If approved, sibeprenlimab would enable individuals living with IgA nephropathy to self-inject once every four weeks.”
The investigational drug has also received breakthrough therapy designation due to its potential to address unmet medical needs in treating this progressive kidney disorder, which often leads to end-stage renal disease under current therapies.
Originally known as VIS649, sibeprenlimab was developed by Visterra, a wholly owned subsidiary of Otsuka. Visterra conducted both pre-clinical and early-stage trials.
The mechanism of action for sibeprenlimab involves binding to and inhibiting APRIL, thereby reducing levels of immunoglobulin A (IgA) and galactose-deficient IgA1 (Gd-IgA1). This reduction is anticipated to decrease immune complex formation and their subsequent deposition in kidney tissues, lowering proteinuria and inflammation.
By inhibiting APRIL, sibeprenlimab may effectively target one of the main drivers of nephron loss in IgAN patients. This targeted approach could slow kidney damage progression and delay the onset of end-stage kidney disease (ESKD), offering a new therapeutic avenue for managing this chronic condition.
