FDA Approves First Treatment for Warm Autoimmune Hemolytic Anemia

The U.S. FDA has approved nipocalimab-aahu (Imaavy) as the first specific therapy for adults and adolescents aged 12 and older with warm autoimmune hemolytic anemia (wAIHA). This approval, based on results from the Phase 2/3 ENERGY trial, offers a new treatment option for patients with this rare autoimmune blood disorder, particularly those previously treated with corticosteroids.