The US Food and Drug Administration (FDA) has accepted Otsuka Pharmaceutical’s biologics licence application for sibeprenlimab for review. The monoclonal antibody selectively inhibits the activity of A PRoliferation-Inducing Ligand (APRIL) in the adult population with immunoglobulin A nephropathy (IgAN).
IgAN is a progressive, chronic kidney condition that can lead to end-stage kidney disease over time, even with optimised standard care.
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The application is supported by outcomes from the Phase III VISIONARY and Phase II ENVISION clinical trials, with the former meeting its primary goals.
In the VISIONARY trial, the antibody showed a significant decrease in 24-hour urinary protein-to-creatinine ratio after nine months of treatment against a placebo.
Based on outcomes from the ENVISION trial, the antibody has secured breakthrough therapy designation.
Sibeprenlimab potentially reduces the levels of IgA and Gd-IgA1, and consequently, the formation of harmful immune complexes.
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By GlobalDataFormulated as a single-dose prefilled syringe for subcutaneous injection, it can be self-administered every four weeks.
The antibody is designed and engineered by Otsuka’s subsidiary Visterra, which carried out its pre-clinical as well as early-stage studies.
The US regulator has set a Prescription Drug User Fee Act target action date for 28 November 2025.
Otsuka pharmaceutical development and commercialisation chief medical officer and executive vice-president John Kraus steted: “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 IgAN to self-inject once every four weeks. We are thankful to share a potential treatment that could offer important clinical benefits and convenience to those living with this disease.”
