Johnson & Johnson Says US FDA Approves Imaavy for Warm Autoimmune Hemolytic Anemia

04:09 AM EDT, 08/25/2026 (MT Newswires) -- Johnson & Johnson (JNJ) said late Monday the US Food and Drug Administration has approved Imaavy for adults and pediatric patients 12 years and older with warm autoimmune hemolytic anemia who are currently or previously treated with corticosteroids. The approval is based on the results of a phase 2/3 study in which Imaavy showed that three times as many patients achieved durable hemoglobin levels compared with placebo by 24 weeks, the company said. Johnson & Johnson said the treatment is the first FDA-approved treatment for warm autoimmune hemolytic anemia. The treatment also enabled reductions in corticosteroid use, the company said.