Call our 24 hours, seven days a week helpline at 800.272.3900

24/7 Helpline 800.272.3900
Donate

Alzheimer’s Association Statement on FDA Complete Response Letter for Donanemab

Alzheimer’s Association Statement on FDA Complete Response Letter for Donanemab
Share or Print this page
Share or Print this page
January 19, 2023
Email: media@alz.org
Share or Print this page
CHICAGO, January 19, 2023 — The Alzheimer’s Association appreciates the Food and Drug Administration’s (FDA) methodical process in reviewing treatments for Alzheimer’s disease. The FDA’s determination that additional data is required to reach a decision on accelerated approval of donanemab (Lilly) demonstrates the rigorous approach the agency takes in reviewing individual treatments.

The donanemab Phase 2 Alzheimer’s trial showed significant slowing of decline on a measure of memory, thinking and daily function in people living with early Alzheimer’s, compared to placebo.

On behalf of our constituents, we look forward to the Phase 3 trial topline data read-out expected later this year, and the outcome of ongoing discussions between the company and the FDA.
 

About the Alzheimer's Association

The Alzheimer’s Association is a worldwide voluntary health organization dedicated to Alzheimer’s care, support and research. Our mission is to lead the way to end Alzheimer's and all other dementia — by accelerating global research, driving risk reduction and early detection, and maximizing quality care and support. Our vision is a world without Alzheimer's and all other dementia®. Visit alz.org or call 800.272.3900.

Keep Up With Alzheimer’s News and Events

We use cookies to improve your experience on this website. Learn about options for managing your personal data in our Privacy Policy.