FDA advisers endorse Eli Lilly’s early-stage Alzheimer’s drug donanemab

On Monday, a panel of independent advisers to the US Food and Drug Administration voted to endorse Eli Lilly’s drug donanemab, a monoclonal antibody designed to slow the progression of early symptomatic Alzheimer’s disease, agreeing that it was safe and effective.

On Monday, a panel of independent advisers to the US Food and Drug Administration voted to endorse Eli Lilly’s drug donanemab, a monoclonal antibody designed to slow the progression of early symptomatic Alzheimer’s disease, agreeing that it was safe and effective. One in three older Americans dies with Alzheimer’s disease or another form of dementia, according to the Alzheimer’s Association, killing more people than prostate and breast cancer combined. Donanemab works by helping the body remove amyloid plaque buildups in the brain that are a hallmark of Alzheimer’s disease. These plaques are harmful deposits that can form in the brain as people age. Removing the plaque seems to slow down the brain changes that seem to happen with Alzheimer’s. As the drug enters the brain it binds to the amyloid plaques and its presence catches the attention of the immune system that facilitates the plaque removal. There is no cure and there is still no drug to prevent the development of Alzheimer’s, but donanemab and Leqembi, another drug that is already on the market made by Eisai and Biogen, has been shown to slow the progression of the disease in its early stages. Lilly told the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee that its data from late-stage clinical research showed “highly meaningful results” for patients who took donanemab, with a 37% lower risk of progression of the disease over a year and a half compared to patients who got the placebo.