Cleveland Alzheimer's Disease Research Center

FDA approves a new medication for Alzheimer’s disease:

On July 2, the U.S. Food and Drug Administration (FDA) approved donanemab which has been developed by Eli Lilly and will be marketed under the name Kisunla™ for the treatment of people living with early symptomatic Alzheimer’s disease, which includes mild cognitive impairment and the mild dementia stage of Alzheimer’s disease, with confirmed amyloid plaques. Amyloid is a protein produced naturally in the body that can clump together to create amyloid plaques characteristic of Alzheimer’s disease. The excessive buildup of amyloid plaques in the brain may lead to memory and thinking issues associated with Alzheimer’s disease.

Donanemab is amyloid plaque-targeting therapy with evidence to support stopping therapy when amyloid plaques are sufficiently lowered and will be available as a once-monthly intravenous (IV) infusion.  A late-stage clinical trial with this new compound showed meaningful results for patients who took donanemab, with about 35% lower risk of progression of the disease over a year and a half versus in patients who received a placebo.   This amounted to a 4.5 – 7.5 months delay in progression on the clinical scales used to measure decline by the end of the study. Donanemab reduced amyloid plaques on average by 61% at 6 months, 80% at 12 months, and 84% at 18 months compared to the start of the study.