Johnson & Johnson announced positive results from a pivotal Phase 2/3 study of its drug, IMAAVY (nipocalimab), for warm autoimmune hemolytic anemia (wAIHA). wAIHA is a rare and serious blood disorder with no currently approved therapies. The study showed the treatment rapidly and sustainably increased hemoglobin levels in adult patients compared to a placebo.
The trial met its primary endpoint. Significantly more patients treated with IMAAVY achieved a durable hemoglobin response. The study also met key secondary goals. These included a reduction in patient-reported fatigue and a decrease in corticosteroid use. IMAAVY's safety profile remained consistent with previous studies. The company presented these findings at the European Hematology Association 2026 Congress. The results support the company's submission to the FDA. The FDA has already granted the drug priority review.