Japanese pharmaceutical company Otsuka has received FDA accelerated approval for its antibody drug that treats a disease affecting the kidneys’ ability to filter waste, reports Endpoint News.
The decision to green-light sibeprenlimab for IgA nephropathy (IgAN) was based on data from a phase 3 trial called VISIONARY in which sibeprenlimab reduced levels of protein in the urine, also known as proteinuria, by just more than half, versus placebo. Proteinuria is a biomarker of kidney function.
Otsuka obtained the rights to sibeprenlimab during its $430m acquisition of Visterra in 2018. The drug will be marketed as Voyxact. Pricing information wasn’t immediately available.
Voyxact is the first drug of its class to clinch an approval in IgAN. It works by blocking a ligand called APRIL which is believed to drive the production of the abnormal IgA protein that builds up in the kidneys. These protein deposits damage the delicate filters that run through the kidneys, causing tissue damage and scarring.
“We’re really hoping that in addition to improving symptoms, [Voyxact] will actually improve long-term kidney outcomes … and has the potential for disease modification,” Otsuka Chief Medical Officer John Kraus told Endpoints News before the approval was granted.
Vera Therapeutics is also advancing an APRIL-directed drug for IgAN called atacicept. The biotech has shared Phase3 data and filed its drug for accelerated approval. Atacicept also targets a different family of ligands called BAFF. But Voyxact is arguably the more convenient option thanks to its once-monthly injection schedule, compared with atacicept’s once-weekly regimen.
Meanwhile, Vertex is also advancing a dual APRIL/BAFF inhibitor called povetacicept that it says has “pipeline-in-a-product” potential.
The IgAN market is already highly competitive. Novartis’s factor B inhibitor Fabhalta won accelerated approval for IgAN in August 2024, and cleared a confirmatory trial last month. In April, the Swiss company’s endothelin A receptor antagonist Vanrafia also clinched an accelerated approval for IgAN.
Travere Therapeutics’ Filspari and Calliditas Therapeutics’ Tarpeyo have been on the market for some years. All four of the drugs are taken orally, which patients generally tend to prefer over injections.
How well Voyxact does commercially could also depend on estimated glomerular filtration rate data from the VISIONARY study, which is expected in early 2026. This is a more robust measure of kidney function compared with proteinuria. The company says that data are intended to support traditional approval.
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