FDA Approves Atacicept for IgA Nephropathy - Report - MDSpire

FDA Approves Atacicept for IgA Nephropathy

The approval was based on reduced proteinuria, and an ongoing trial is required to determine whether atacicept slows long-term kidney function decline.

  • By

  • Kathryn Wighton

  • July 7, 2026

  • 3 min

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Clinical Report: FDA Approves Atacicept for IgA Nephropathy

Overview

The FDA has granted accelerated approval for atacicept-vymj to reduce proteinuria in adults with primary IgA nephropathy at risk for disease progression.

Background

Primary immunoglobulin A (IgA) nephropathy is a kidney disease characterized by the accumulation of an abnormal IgA antibody in the kidneys, leading to inflammation and potential kidney failure. The condition often results in proteinuria and progressive loss of kidney function.

Data Highlights

StudyInterventionProteinuria Reduction
NCT04716231Atacicept 150 mg weekly46% at 9 months
NCT04716231PlaceboNot specified

Key Findings

  • Atacicept achieved a 46% reduction in proteinuria at 9 months compared to placebo.
  • The drug targets both B-cell activating factor and A Proliferation Inducing Ligand.
  • Common adverse reactions include infections and injection site reactions.
  • Patients should be evaluated for active infections before starting treatment.
  • Continued approval of atacicept is contingent on the completion of ongoing clinical trials.

Clinical Implications

Patients should be evaluated for active infections before treatment initiation.

Conclusion

The accelerated approval of atacicept for IgA nephropathy represents a new therapeutic option.

Related Resources & Content

  1. FDA, FDA, 2026 -- FDA Approves New Treatment to Reduce Proteinuria in Adults with Primary Immunoglobulin A Nephropathy
  2. New England Journal of Medicine, NEJM, 2026 -- A Phase 3 Trial of Atacicept in Patients with IgA Nephropathy
  3. Retinal Physician — SUBSPECIALTY NEWS: Izervay FDA approval, ReST committee updates on Syfovre, and more.
  4. Retinal Physician — SUBSPECIALTY NEWS: FDA approves Cimerli, GATHER2 GA trial meets primary endpoint, and more.
  5. The ASCO Post — FDA Approves Ivosidenib/Azacitidine for Certain Patients With Newly Diagnosed AML
  6. Retinal Physician — FDA Approves Ultomiris for Neuromyelitis Optica Spectrum Disorder
  7. FDA Approves First Drug to Decrease Urine Protein in IgA Nephropathy
  8. FDA Approves New Treatment to Reduce Proteinuria in Adults with Primary Immunoglobulin A Nephropathy | FDA
  9. A Phase 3 Trial of Atacicept in Patients with IgA Nephropathy | New England Journal of Medicine

Original Source(s)

FDA Approves Atacicept for IgA Nephropathy

  • by Kathryn Wighton

  • July 7, 2026

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