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.
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By
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Kathryn Wighton
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August 25, 2026
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Clinical Scorecard: FDA approves first therapy for warm autoimmune hemolytic anemia
At a Glance
| Category | Detail |
|---|
| Condition | Warm Autoimmune Hemolytic Anemia (wAIHA) |
| Key Mechanisms | Nipocalimab binds to and blocks the neonatal Fc receptor, reducing circulating immunoglobulin G antibodies while preserving B-cell function. |
| Target Population | Adults and pediatric patients aged 12 years and older with wAIHA previously treated with corticosteroids. |
| Care Setting | Clinical treatment for autoimmune hemolytic anemia. |
Key Highlights
- Nipocalimab is the first therapy approved specifically for wAIHA.
- Approval based on the phase 2/3 ENERGY trial involving 115 adults.
- Participants receiving nipocalimab had a higher durable hemoglobin response compared to placebo.
- Common adverse reactions include peripheral edema, diarrhea, and fever.
- The approved dosing regimen is 30 mg/kg intravenously every 4 weeks.
Guideline-Based Recommendations
Diagnosis
- Diagnosis of wAIHA involves identifying autoantibodies that destroy red blood cells.
Management
- Nipocalimab is indicated for patients with wAIHA who have been treated with corticosteroids.
Monitoring & Follow-up
- Monitor hemoglobin levels and potential adverse reactions during treatment.
Risks
- Increased risk of venous thrombotic events, acute renal failure, and infections.
Patient & Prescribing Data
Adults and pediatric patients aged 12 years and older with wAIHA.
Nipocalimab shows efficacy in increasing hemoglobin levels and reducing fatigue.
Clinical Best Practices
- Consider nipocalimab for patients with wAIHA who have not responded to corticosteroids.
- Regularly assess for adverse reactions during treatment.
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