The US Food and Drug Administration has approved nipocalimab-aahu (IMAAVY) as the first treatment for warm autoimmune hemolytic anemia (wAIHA) in adults and pediatric patients ages 12 years and older who are currently or previously treated with corticosteroids.
Nipocalimab-aahu is an immunoselective neonatal fragment crystallizable receptor blocker designed to reduce pathogenic immunoglobulin G autoantibodies while preserving B-cell function, according to Johnson & Johnson, the manufacturer of the drug.
The approval is based on the phase 2/3 ENERGY study, which evaluated the efficacy and safety of intravenous nipocalimab in patients with warm autoimmune hemolytic anemia. at the European Hematology Association 2026 meeting in June.
“These data from the phase 2/3 ENERGY study showed the rapid onset of effect and durable improvement in anemia which occurs by targeting the autoantibody-mediated destruction of red blood cells in people living with warm autoimmune hemolytic anemia,” said Bruno Fattizzo, MD, assistant professor at the Department of Oncology and Hematology-Oncology, University of Milan, Italy. “Achieving hemoglobin improvements this quickly and at this scale is important in clinical practice, as it could help improve the debilitating fatigue that people living with warm autoimmune hemolytic anemia experience.”
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