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

Alzheimer’s Association Statement on FDA Complete Response Letter for Donanemab
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January 19, 2023
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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 or call 800.272.3900.

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