Johnson & Johnson submits sBLA to FDA for approval of Imaavy

Johnson & Johnson announced the submission of a supplemental Biologics License Application to the U.S. FDA seeking approval of Imaavy as the first-ever treatment for patients with warm autoimmune hemolytic anemia. This rare and serious autoantibody disease affects approximately 1 in 8,000 in the United States and currently has no approved treatments despite substantial unmet need. The condition is associated with significant morbidity and mortality, with those living with the disease found to experience a 20-30% higher risk of death.