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.

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.

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.

Diagnosis of wAIHA involves identifying autoantibodies that destroy red blood cells.

Nipocalimab is indicated for patients with wAIHA who have been treated with corticosteroids.

Increased risk of venous thrombotic events, acute renal failure, and infections.

Adults and pediatric patients aged 12 years and older with wAIHA.

Nipocalimab shows efficacy in increasing hemoglobin levels and reducing fatigue.

Consider nipocalimab for patients with wAIHA who have not responded to corticosteroids.
Regularly assess for adverse reactions during treatment.

Clinical Scorecard: FDA approves first therapy for warm autoimmune hemolytic anemia