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July 8, 2026 – This week marks another important milestone for the IgA nephropathy (IgAN) community. The U.S. Food and Drug Administration (FDA) has granted accelerated approval to atacicept (TRUTAKNA), Vera Therapeutics’ 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 rare 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.
Atacicept is the first FDA-approved treatment for IgAN that targets both B-cell Activating Factor (BAFF) and A Proliferation-Inducing Ligand (APRIL), which are two proteins involved in the immune response that contribute to the production of abnormal IgA. By blocking both BAFF and APRIL, atacicept is designed to address the underlying immune processes that drive the disease.
The FDA’s approval was based on interim results from the ongoing Phase 3 ORIGIN 3 clinical trial, which showed:
- A 46% reduction in proteinuria from baseline after 36 weeks of treatment
- A 42% greater reduction in proteinuria compared with placebo
- Consistent reductions in proteinuria across patient groups regardless of age, sex, region, baseline proteinuria, baseline eGFR, or use of SGLT2 inhibitors
The study also found that the atacicept was generally well tolerated, the most common side effects were infections and injection site reactions.
It is not yet known whether atacicept slows long-term kidney function decline. The ongoing Phase 3 ORIGIN 3 study will continue to evaluate this, with results expected later this year.
With today’s approval, there are now seven FDA-approved treatment options for rare, protein-spilling kidney diseases, including therapies for IgAN, focal segmental glomerulosclerosis (FSGS), C3 glomerulopathy (C3G), and primary IC-MPGN.
- TRUTAKNA (atacicept) – Approved for IgAN
- VOYXACT (sibeprenlimab) – Approved for IgAN
- EMPAVELI (pegcetacoplan) – Approved for C3G and primary IC-MPGN
- FABHALTA (iptacopan) – Approved for C3G and IgAN
- FILSPARI (sparsentan) – Approved for IgAN and FSGS
- TARPEYO (budesonide) – Approved for IgAN
- VANRAFIA (atrasentan) – Approved for IgAN
The growing number of approved treatment options represents remarkable progress for the rare kidney disease (RKD) community. Just a few years ago, there were no FDA-approved treatments for any rare, protein-spilling kidney disease. Today, patients living with RKD have more treatment options than ever before.
NephCure remains committed to ensuring every person affected by rare, protein-spilling kidney disease has equitable access to the care, treatments, and support they need.
If you or a loved one has IgAN, talk with your nephrologist to determine whether atacicept or another approved treatment may be appropriate for your individual treatment plan.
Looking for expert care? Use NephCure’s Specialist Finder to locate a nephrologist with expertise in rare kidney diseases near you.
To read Vera Therapeutics’ full announcement about the FDA approval of atacicept, click here.
To learn more about IgA nephropathy and explore NephCure’s educational resources, click here.
