FDA Approves IMAAVY (nipocalimab-aahu) as First-Ever Treatment for Warm Autoimmune Hemolytic Anemia

The U.S. Food and Drug Administration (FDA) has granted approval to IMAAVY (nipocalimab-aahu) for the treatment of warm autoimmune hemolytic anemia (wAIHA) in adults and pediatric patients 12 years and older who are currently or have previously been treated with corticosteroids. This marks the first time a therapy has been specifically proven safe and effective for wAIHA, a rare, life-threatening autoantibody disease where IgG autoantibodies destroy red blood cells. The approval was based on a pivotal Phase 2/3 study demonstrating a durable hemoglobin response.