The U.S. Food and Drug Administration granted accelerated approval Friday for lecanemab, an Alzheimer’s disease drug for which studies showed the promising biological effect of removal of the brain’s amyloid buildup that occurs in the disease.
University of Michigan Health, Michigan Medicine, has experts available to talk about the accelerated approval and what it could mean for the future of patient care for Alzheimer’s.
Available:
Judith Heidebrink, M.D. – Neurologist and Clinical Core Co-Lead of the Michigan Alzheimer’s Disease Center
“While lecanemab is not a cure for Alzheimer’s disease, it could help someone with mild Alzheimer’s symptoms maintain their independence for a longer period of time. There are side effects, and, in some cases, the risk of side effects will outweigh the potential benefit. So, as with all drug treatments, the risks and benefits must be considered carefully for each individual patient. Lecanemab’s potential side effects include brain swelling and/or bleeding, so anyone treated with it will need close monitoring, including MRI scans to look for side effects.
We do not know if lecanemab can help someone with more advanced Alzheimer’s symptoms because the studies have focused on early symptoms. However, there are reasons to believe that a benefit is unlikely with more advanced disease. Could lecanemab prevent symptoms of Alzheimer’s disease if given to someone at risk? We don’t know yet, but we are excited to be participating in a study that will help answer that question, the AHEAD 3-45 study.”
Henry Paulson, M.D., Ph.D. – Neurologist and Director of the Michigan Alzheimer’s Disease Center
“Alzheimer’s disease is a complex disorder, with many factors contributing to its progressive course, one of them being amyloid. The slowing of disease symptoms by lecanemab argues that targeting amyloid is a viable treatment strategy. While lecanemab doesn’t represent a cure, it gives me hope that we are now reaching the era of disease-modifying treatments for dementia.”
