Alzheimer’s Disease Treatment Special Notice – July 7, 2023:

The U.S. Food and Drug Administration (FDA) gave traditional “full” approval to lecanemab-irmb injection (Leqembi™), previously approved in January under the accelerated approval mechanism. Lecanemab is approved for treatment of persons with early Alzheimer’s disease, including persons with mild cognitive impairment due to Alzheimer’s disease, or mild dementia due to Alzheimer’s disease. This drug, is a monoclonal antibody, and is the first drug approved that is proven to slow the clinical progression of Alzheimer’s disease. The drug removes Alzheimer’s plaques from the brain, and consistently slows progression of disease by 27% to 37% depending on the measure used, as shown in a large phase 3 trial, CLARITY AD, which was performed at Columbia University and other centers around the world, and published in the New England Journal of Medicine in late 2022. Lecanemab treatment, which currently is delivered by intravenous infusion every two weeks, does have some risk of side-effects of brain swelling (edema) and brain bleeding (hemorrhage). Individuals with certain genetic factors (one or more apolipoprotein E e4 alleles) have more risk than others of these side effects. Medicare has announced that it will be providing coverage for this drug, so long as patients allow their practitioners to submit their information in a secure privacy-protected “registry” database, which will allow continued safety assessment of the treatment.