FDA approves Imaavy, first cleared treatment for warm autoimmune hemolytic anemia

Every four weeks, a patient receiving Imaavy gets the drug through a vein, with the dose set by body weight. The U.S. Food and Drug Administration has approved Johnson & Johnson’s expanded use of the treatment for warm autoimmune hemolytic anemia, or wAIHA — a rare blood disorder — making it the first treatment cleared for the condition.

The approval covers patients aged 12 and older who are currently or were previously treated with steroids. Reuters reported the decision, which STAT said was based on a mid-to-late-stage study of 115 adults.

wAIHA is uncommon but serious. About 1 in 8,000 people have the disorder, and 1 to 3 new cases are diagnosed annually per 100,000 people. The condition is life-threatening, according to the report.

The treatment is administered by intravenous infusion every four weeks. The dose depends on the patient’s weight, giving clinicians a defined schedule for an option that is now specifically cleared for wAIHA.

The approval is based on adult trial data, while the permitted patient population begins at age 12.