The Alzheimer’s Association welcomes today’s U.S. Food and Drug Administration (FDA) advisory committee’s unanimous finding that donanemab (Eli Lilly) is effective for the treatment of early Alzheimer’s disease, which includes mild cognitive impairment and mild Alzheimer’s dementia, and that the treatment’s benefits outweigh the risks.
If approval is granted by the FDA, donanemab will be the second traditional approval of an Alzheimer’s treatment that changes the underlying course of the disease, and the third FDA approval overall in this class of treatments.
The next regulatory step toward approval of the treatment is FDA review.
https://www.alz-net.org/
