The Alzheimer’s Association released the following statement:
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.
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