Johnson & Johnson Announces Positive Phase 3 Results for Nipocalimab in Warm Autoimmune Hemolytic Anemia

Johnson & Johnson today announced positive results from the Phase 3 BEATRICE trial evaluating nipocalimab in patients with warm autoimmune hemolytic anemia (wAIHA). The trial met its primary endpoint, demonstrating a statistically significant improvement in hemoglobin response compared to placebo. Nipocalimab is an anti-FcRn antibody that reduces IgG antibody levels, including the pathogenic autoantibodies that cause wAIHA. wAIHA is a rare, life-threatening autoimmune condition where the immune system destroys red blood cells. These results support regulatory submissions for nipocalimab in wAIHA.