FDA approves Alzheimer’s disease drug donanemab

Graphic image noting the words FDA Approved

On July 2, 2024, the U.S. Food and Drug Administration (FDA) approved Kisunla (donanemab-azbt) injection for the treatment of Alzheimer’s disease.

Kisunla is the third and latest of a new category of medications, called monoclonal antibodies, to be approved by the FDA. These treatments are designed to slow the progression of early-stage Alzheimer’s disease, and they represent an important advancement in the ongoing fight to effectively treat Alzheimer’s disease.

“Alzheimer's disease is a devastating disease for the person diagnosed and their loved ones,” said Teresa Buracchio, director of the Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research. “The trial data demonstrated, convincingly, that Kisunla reduces the rate of cognitive and functional decline in patients in the mild cognitive impairment and mild dementia stages of Alzheimer’s disease. Today’s approval is evidence of the FDA’s commitment to helping more safe and effective drugs to treat Alzheimer’s disease become available.”

The FDA published the announcement in a  press release, “FDA approves treatment for adults with Alzheimer’s disease,” on July 2, 2024. Buracchio’s statement can be found in the “FDA Roundup: July 2, 2024.”