The U.S. Food and Drug Administration (FDA) approved Kisunla (donanemab-azbt) injection for the treatment of Alzheimer’s disease in adults with mild cognitive impairment or mild dementia. Alzheimer’s affects over 6.5 million Americans and is characterized by brain changes leading to memory and thinking impairments. This is the third approval of an Alzheimer’s treatment that changes the underlying course of the disease. Administered intravenously every four weeks, Kisunla’s efficacy was demonstrated in a double-blind, placebo-controlled, parallel-group clinical trial showing significant reductions in clinical decline.

The FDA approval notice may be found here.