FDA approves IMAAVY® (nipocalimab-aahu) as first-ever treatment for warm autoimmune hemolytic anemia (wAIHA), representing a landmark advancement for patients

FDA approves IMAAVY® (nipocalimab-aahu) as first-ever treatment for warm autoimmune hemolytic anemia (wAIHA), representing a landmark advancement for patients

* IMAAVY is an immunoselective FcRn blocker designed to target and reduce pathogenic immunoglobulin G (IgG) autoantibodies while also preserving B-cell function * Warm autoimmune hemolytic anemia is a rare, life-threatening disease in which autoantibodies cause the destruction of red blood cells, leading to severe anemia and debilitating fatigue * The approval is based on the pivotal Phase 2/3 study which demonstrated durable hemoglobin response(a) * A mean increase in hemoglobin of 1 g/dL at Week 1(b) and improvement in FACIT-Fatigue(c) score at Week 24 were observed in IMAAVY-treated patients(d) SPRING HOUSE, Pa., Aug. 24, 2026 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today announced the U.S. Food and Drug Administration (FDA) approval of IMAAVY(®) (nipocalimab-aahu) for the treatment of warm autoimmune hemolytic anemia (wAIHA) – a rare, life-threatening autoantibody disease – in adults and pediatric patients 12 years of age and older currently or previously treated with corticosteroids. The approval, which follows FDA Priority Review , marks the first time a therapy was proven safe and effective specifically for the treatment of wAIHA.(1)