Eli Lilly: FDA to convene a committee on donanemab
The application was based on the results of a Phase III study evaluating the safety and efficacy of donanemab in 1736 participants from eight countries, aged 60 to 85, with early symptomatic Alzheimer's disease (mild cognitive impairment or mild dementia due to Alzheimer's disease) with confirmed neuropathology.
The results of the study (TRAILBLAZER-ALZ 2) were published in the Journal of the American Medical Association (JAMA).
The company says it will continue its study of donanemab, notably via the so-called TRAILBLAZER-ALZ-3 trial, which will look at donanemab as a potential preventive treatment for Alzheimer's disease.
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