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December 2, 2025 — Last week, another major step forward was made for the IgA nephropathy (IgAN) community. The FDA granted accelerated approval for VOYXACT (sibeprenlimab-szsi), Otsuka’s new treatment for adults with primary IgAN who are at risk for disease progression.
The FDA’s accelerated approval program allows for earlier access to treatments that address serious conditions with unmet medical needs by using a surrogate endpoint. Defined by the FDA, a surrogate endpoint is a clinical trial endpoint used as a substitute for a direct measure of how a patient feels, functions, or survives. In this case, the surrogate endpoint is proteinuria reduction.
IgAN is a kidney disease in which Immunoglobulin A (IgA) builds up in the kidney. IgA is a protein in the blood and is also part of the immune system. Excess IgA can cause inflammation in the kidney and over time, this leads to scarring in the kidney tissue. The severity of kidney disease caused by IgAN varies from person to person. As IgAN progresses, it reduces the kidneys’ ability to filter waste from the blood.
While VOYXACT is not the first treatment approved for IgAN, it is the first therapy that blocks a molecule called A-PRoliferation-Inducing-Ligand (APRIL). APRIL plays a role in creating harmful IgA that drives the disease process. By blocking APRIL, VOYXACT reduces levels of galactose-deficient IgA1 (Gd-IgA1), the form of IgA closely linked to IgAN.
The FDA’s approval for VOYXACT was granted based on interim data from Otsuka’s Phase 3 VISIONARY study, which showed:
- A 51% placebo-adjusted reduction in proteinuria at 9 months
- Patients on VOYXACT saw a 50% decrease in proteinuria compared to a 2% decrease in the placebo group.
- Reductions were seen at 9 months of treatment among 320 participants.
Proteinuria is a widely accepted indicator of kidney health in IgAN. Lowering proteinuria is associated with slowing damage to the kidneys, which is why it is used as a surrogate marker for accelerated approval.
It is not yet known whether VOYXACT slows long-term kidney function decline. The ongoing Phase 3 VISIONARY study will evaluate this, with results expected in 2026.
With this latest approval, there are now six FDA-approved treatment options for rare kidney disease:
- VOYXACT (sibeprenlimab-szsi) – Approved for IgAN
- EMPAVELI (pegcetacoplan) – Approved for C3G and primary IC-MPGN
- FABHALTA (iptacopan) – Approved for C3G and IgAN
- FILSPARI (sparsentan) – Approved for IgAN
- TARPEYO (budesonide) – Approved for IgAN
- VANRAFIA (atrasentan) – Approved for IgAN
If you or a loved one has IgAN, talk with your nephrologist to determine whether VOYXACT or another treatment option may be right for you.
To read Otsuka’s full press release about the FDA approval of VOYXACT, click here.
For more information about IgA nephropathy or to explore NephCure’s educational resources, click here.
