Posted by Michael Wonder on 25 Feb 2026
Johnson & Johnson seeks FDA approval of Imavvy (nipocalimab-aahu) as the first-ever FDA approved treatment for warm autoimmune hemolytic anemia
24 February 2026 - Data from the pivotal ENERGY trial showed Imavvy produced a rapid and durable hemoglobin response in wAIHA.
Johnson & Johnson today announced the submission of a supplemental biologics license application to the US FDA, seeking approval of Imavvy (nipocalimab-aahu) as the first-ever treatment for patients with warm auto-immune haemolytic anemia.
