The FDA approved Johnson & Johnson’s IMAAVY (nipocalimab-aahu) for adults and children aged 12 and older with warm autoimmune hemolytic anemia (wAIHA).
This marks the first and only therapy specifically approved for this life-threatening autoimmune blood disorder. The agency granted the approval following a Priority Review designation.
wAIHA causes the body’s antibodies to destroy red blood cells, resulting in severe anemia and fatigue. IMAAVY functions as an FcRn blocker to reduce pathogenic IgG autoantibodies responsible for cell destruction.
A pivotal Phase 2/3 study demonstrated that the treatment produces a durable hemoglobin response in patients. This is the second FDA approval for IMAAVY, following its 2025 clearance for generalized myasthenia gravis.