Johnson & Johnson's Imaavy Gets FDA Priority Review for Rare Blood Disorder

 Priority Review is granted to medicines that may offer significant improvements in safety or effectiveness for serious conditions like warm autoimmune hemolytic anemia, a life-threatening disease in which pathogenic immunoglobulin G autoantibodies attach to and destroy red blood cells, leading to debilitating anemia

IMAAVY is designed to target the underlying cause of warm autoimmune hemolytic anemia by reducing circulating immunoglobulin G, including autoantibodies, while preserving critical immune functions

Pivotal study showed rapid and durable hemoglobin responsea and fatigue improvementb compared to placebo in patients with warm autoimmune hemolytic anemia

https://www.prnewswire.com/news-releases/fda-grants-priority-review-for-imaavy-nipocalimab-aahu-as-the-potential-first-approved-treatment-for-people-living-with-warm-autoimmune-hemolytic-anemia-waiha-302753581.html