Another Alzheimer’s Disease Antibody Therapy Receives Positive FDA Feedback

A U.S. Food and Drug Administration committee unanimously voted to recommend the approval of an Eli Lilly medication for early Alzheimer’s disease.

According to the New York Times on June 10, 2024, this news indicates the FDA may approve donanemab for people diagnosed with mild cognitive impairment due to Alzheimer’s in late 2024.

To support their request, Lilly submitted data from a JAMA Original Investigation in the early stages of the disease, with either mild cognitive impairment or mild dementia.

Donanemab, similar to the approved LEQEMBI™, is not a vaccine but is given as intravenous infusions.