FDA Approves Atacicept for IgA Nephropathy - Summary - MDSpire
Coming Soon: Introducing MDSpire News. Learn more
Conexiant’s news site is now MDSpire News. Learn more

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

Share

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

Related Content

FDA approves first therapy for warm autoimmune hemolytic anemia

The phase 2/3 ENERGY trial evaluated durable hemoglobin response with nipocalimab vs placebo in adults with warm autoimmune hemolytic anemia.

Emergency diagnosis may flag poor outcomes beyond cancer

Across 13 noncancer conditions, emergency diagnosis was common and associated with higher 1-year mortality.

FDA approves first therapy for Alexander disease

The antisense oligonucleotide reduces production of the abnormal protein that accumulates in supportive cells in the brain.