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

PR Newswire

SPRING HOUSE, Pa., Aug. 24, 2026

IMAAVY is an immunoselective FcRn blocker designed to target and reduce pathogenic immunoglobulin G (IgG) autoantibodies while also preserving B-cell functionWarm 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 fatigueThe approval is based on the pivotal Phase 2/3 study which demonstrated durable hemoglobin responseaA mean increase in hemoglobin of 1 g/dL at Week 1b and improvement in FACIT-Fatiguec score at Week 24 were observed in IMAAVY-treated patientsdSPRING 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