The U.S. Food and Drug Administration has granted full approval to the new Alzheimer's disease drug lecanemab (brand name Leqembi). The medication was granted accelerated approval in January.
Judith Heidebrink, neurologist and clinical core co-lead of the Michigan Alzheimer's Disease Center at the University of Michigan Health, Michigan Medicine, can comment.
Heidebrink has been involved in collaborative clinical trials in dementia for more than 20 years, including phase I-III studies focusing on the prevention and treatment of Alzheimer's dementia.
In addition, she led U-M's participation in the Alzheimer's Disease Neuroimaging Initiative since the inception of this longitudinal observational study of brain imaging and other biomarkers in the progression from normal aging to dementia.
"The full FDA approval of lecanemab is a remarkable milestone in the treatment of Alzheimer's disease," she said. "We now have a disease-modifying therapy approved based on its clinical benefit. While not a cure, lecanemab allows people with early symptoms to stay independent longer. That's what our patients really value-staying independent. Serious side effects can occur, and the risk of side effects is greater in certain individuals. So, it will be important to have a careful discussion of the risks and benefits before considering treatment with lecanemab."
