Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) has approved IMAAVY® (nipocalimab-aahu) as the first therapy specifically indicated for the treatment of warm autoimmune hemolytic anemia (wAIHA). The approval extends to adult and pediatric patients aged 12 years and older who are currently or previously treated with corticosteroids.
wAIHA is a rare, antibody-driven condition that causes premature destruction of red blood cells. IMAAVY functions as an immunoselective neonatal Fc receptor (FcRn) blocker, engineered to selectively reduce disease-driving IgG autoantibodies while preserving essential B-cell immune function.
The FDA decision is supported by robust data from the pivotal Phase 2/3 ENERGY clinical study. In the trial, approximately three times as many patients treated with the approved dose of IMAAVY achieved a durable hemoglobin response compared to those on placebo at 24 weeks, demonstrating meaningful and sustained disease control.
“Today’s announcement marks the second approval for IMAAVY and is an extraordinary milestone for people living with warm autoimmune hemolytic anemia, an underserved community that has waited far too long for an FDA-approved treatment,” said David M. Lee, M.D., Ph.D., Global Immunology Therapeutic Area Head at Johnson & Johnson. “As the first approved therapy for wAIHA, IMAAVY has the potential to redefine disease management, particularly for people with uncontrolled disease.”
This regulatory milestone strengthens the clinical utility of FcRn-targeted therapies across serious antibody-driven autoimmune conditions. IMAAVY provides a much-needed, targeted therapeutic option designed to address the underlying mechanism of hemolytic anemia and improve long-term outcomes for patients navigating this challenging disorder.
Written by: Pragna Biswas
Graphics by: Pramit Hazra
