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Johnson & Johnson seeks FDA approval of IMAAVY® (nipocalimab-aahu) as the first-ever FDA-approved treatment for warm autoimmune hemolytic anemia (wAIHA)
Johnson & Johnson (NYSE: JNJ) today announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA), seeking approval of IMAAVY® (nipocalimab-aahu) as the first-ever treatment for patients with warm autoimmune hemolytic anemia (wAIHA).b This rare and serious autoantibody disease affects approximately 1 in 8,000 in the United States and currently has no approved treatments despite substantial unmet need.1 The condition is associated w
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[{"type":"text","content":"Data from the pivotal ENERGY trial showed IMAAVY® produced a rapid and durable hemoglobin responsea in wAIHA","length":108,"tagName":"p"},{"type":"text","content":"Currently no FDA-approved therapies are available for wAIHA, a rare, heterogeneous, life-threatening disease in which pathogenic immunoglobulin (IgG) autoantibodies attach to and destroy red blood cells, leading to debilitating anemia","length":234,"tagName":"p"},{"type":"text","content":"SPRING HOUSE, Pa., Feb. 24, 2026 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA), seeking approval of IMAAVY® (nipocalimab-aahu) as the first-ever treatment for patients with warm autoimmune hemolytic anemia (wAIHA).b This rare and serious autoantibody disease affects approximately 1 in 8,000 in the United States and currently has no approved treatments despite substantial unmet need.1 The condition is associated with significant morbidity and mortality, with those living with the disease found to experience a 20-30% higher risk of death.2","length":680,"tagName":"p"},{"type":"image","alt":"(PRNewsfoto/Johnson & Johnson)","displaySize":"","headline":null,"caption":"(PRNewsfoto/Johnson & Johnson)","className":"","disableSlideshowImg":false,"size":{"original":{"width":400,"height":37,"url":"https://media.zenfs.com/en/prnewswire.com/f6c13e47c55b1b30082ae2cdc7f55cf9"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/jIgvao1bUyQtFqwMNBmckA--/YXBwaWQ9aGlnaGxhbmRlcjt3PTcwNTtoPTY1O2NmPXdlYnA-/https://media.zenfs.com/en/prnewswire.com/f6c13e47c55b1b30082ae2cdc7f55cf9","width":400,"height":37}},"href":"https://mma.prnewswire.com/media/2333578/Johnson_and_Johnson_Logo_v1.html","hrefExternal":true,"rel":"nofollow"},{"type":"text","content":""People living with warm autoimmune hemolytic anemia face a serious, life-threatening disease with no approved treatment options and a high risk of complications, including profound chronic fatigue, transfusion dependence, and organ failure," said David M Lee, M.D., Ph.D., Global Immunology Therapeutic Area Head, Johnson & Johnson. "The submission of this sBLA represents an important milestone for the wAIHA community and underscores our commitment to advancing targeted, immunoselective therapies ...