The U.S. Food and Drug Administration granted Priority Review for Johnson & Johnson’s supplemental Biologics License Application for IMAAVY (nipocalimab-aahu). The treatment targets warm autoimmune hemolytic anemia (wAIHA), a life-threatening condition where the immune system destroys red blood cells.
This designation shortens the FDA review period to approximately six months. IMAAVY represents the first therapy to receive Priority Review for the treatment of wAIHA.
Results from the pivotal Phase 2/3 ENERGY study support the application. The study showed that IMAAVY achieved a durable hemoglobin response and improved fatigue compared to a placebo. Johnson & Johnson plans to present full trial data at a future medical conference.