Imaavy approved for warm autoimmune hemolytic anemia

What this means

Warm autoimmune hemolytic anemia (wAIHA) is a rare disease in which the immune system mistakenly makes antibodies that attach to red blood cells and cause them to be destroyed, leading to anemia and fatigue. Imaavy (nipocalimab-aahu) is a monoclonal antibody that blocks the neonatal Fc receptor (FcRn), which normally recycles antibodies, so it lowers the level of the harmful autoantibodies driving the disease. In the pivotal trial, patients showed an average hemoglobin increase of 1 g/dL by Week 1 and improved fatigue scores at Week 24. This is the first therapy specifically approved for wAIHA; Imaavy was previously approved for generalized myasthenia gravis.