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
Clinical Scorecard: FDA Approves Atacicept for IgA Nephropathy
At a Glance
Category Detail
Condition Primary Immunoglobulin A Nephropathy Key Mechanisms Targets B-cell activating factor and A Proliferation Inducing Ligand, proteins involved in immune cell survival and maturation. Target Population Adults with primary IgA nephropathy at risk for disease progression. Care Setting Clinical trial and outpatient management.
Key Highlights
Atacicept is the first approved therapy for primary IgA nephropathy. Demonstrated a 46% reduction in proteinuria at 9 months compared to placebo. Accelerated approval granted based on proteinuria reduction. Patients must be evaluated for infections before treatment. Ongoing clinical trial required to verify long-term kidney function benefits. Guideline-Based Recommendations
Diagnosis
Biopsy-confirmed primary IgA nephropathy. Management
Monitor for proteinuria and assess kidney function. Monitoring & Follow-up
Evaluate for active infections before treatment initiation and during therapy. Risks
Increased risk of infections and injection site reactions. Patient & Prescribing Data
Adults with biopsy-confirmed primary IgA nephropathy.
Atacicept administered subcutaneously at 150 mg once weekly.
Clinical Best Practices
Do not administer live vaccines within 30 days prior to treatment or during treatment. Monitor patients for signs of infection during therapy. Related Resources & Content
