Johnson & Johnson Hits Target With IMAAVY In Rare Blood Disorder

Johnson & Johnson announced that IMAAVY (nipocalimab-aahu) achieved its primary endpoint in the Phase 2/3 ENERGY study for warm autoimmune hemolytic anemia (wAIHA). Patients receiving the 30 mg/kg dose were three times more likely to achieve durable hemoglobin improvements compared to placebo over 24 weeks. The drug demonstrated rapid onset of effect, early improvements in fatigue, and reduced steroid use, with a safety profile consistent with its approved indication in myasthenia gravis. The supplemental Biologics License Application has been granted FDA Priority Review.