Johnson & Johnson said the FDA approved the first label expansion for IMAAVY (nipocalimab-aahu) on August 24, 2026.
The expanded indication covers warm autoimmune hemolytic anemia (wAIHA), a rare, potentially life-threatening autoimmune disease in which antibodies destroy red blood cells.
IMAAVY is approved for adults and children aged 12 and older who are currently or previously treated with corticosteroids.
The approval makes IMAAVY the first FDA-approved treatment specifically indicated for wAIHA, addressing a major unmet medical need.
The decision was based on the Phase 2/3 ENERGY study, which showed durable hemoglobin responses and improved fatigue outcomes.
IMAAVY was initially approved in April 2025 for generalized myasthenia gravis in antibody-positive patients aged 12 and older.
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