FDA Approves Atacicept for IgA Nephropathy - Summary - 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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Objective:

To report the FDA's accelerated approval of atacicept for reducing proteinuria in adults with primary IgA nephropathy.

Approach:
  • Clinical Trial Design: The efficacy and safety of atacicept were evaluated in a randomized, double-blind, placebo-controlled clinical trial (NCT04716231) involving adults with biopsy-confirmed primary IgA nephropathy.
  • Treatment Administration: Patients received atacicept 150 mg subcutaneously once weekly or placebo, with the primary endpoint being the change in proteinuria after 9 months.
Key Findings:
  • Atacicept resulted in a 46% reduction in proteinuria at 9 months compared to placebo.
  • Atacicept is the first approved therapy targeting both B-cell activating factor and A Proliferation Inducing Ligand.
Interpretation:

Limitations:
  • The risk of infections associated with atacicept use requires careful patient monitoring.
Conclusion:

Atacicept has received accelerated approval for IgA nephropathy, with ongoing trials needed to confirm long-term benefits.

Sources:

Original Source(s)

FDA Approves Atacicept for IgA Nephropathy

  • by Kathryn Wighton

  • July 7, 2026

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