In a somewhat surprising move, the US Food and Drug Administration (FDA) has declined to grant accelerated approval to Eli Lilly’s donanemab Read the full press release from Eli Lilly here Like aducanumab and lecanemab, which were previously granted accelerated approval by the FDA, donanemab is a monoclonal antibody treatment against the beta amyloid protein that accumulates in the brain of a person with Alzheimer’s disease. Eli Lilly published very promising results for donanemab in 2021, which included demonstration that donanemab could lower amyloid levels in the brain of people with mild cognitive impairment and mild dementia (the basis for…
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