Johnson & Johnson announced that the FDA approved IMAAVY (nipocalimab-aahu) for adults and pediatric patients 12 and older with warm autoimmune hemolytic anemia (wAIHA) who are currently or previously treated with corticosteroids. The approval makes IMAAVY the first therapy specifically proven safe and effective for wAIHA, a rare and potentially life-threatening disease in which autoantibodies destroy red blood cells and cause severe anemia and fatigue. Approval was supported by the Phase 2/3 ENERGY study, which demonstrated durable hemoglobin responses, including a mean hemoglobin increase of 1 g/dL as early as Week 1, while IMAAVY targets disease-driving IgG autoantibodies.
