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New Approval Alert: FDA Approves Eli Lilly’s KisunlaTM (donanemab-azbt) for Alzheimer’s Disease

Jul 2, 2024

On 2 July 2024, Eli Lilly announced that the US FDA has approved its KisunlaTM (donanemab-azbt) for early symptomatic Alzheimer’s Disease (patients with mild cognitive impairment or mild dementia stage of disease).  Once-monthly Kisunla is the first amyloid plaque-targeting therapy with evidence to support stopping therapy when amyloid plaques are removed.  This is reported to result in lower treatment costs and fewer infusions.  


The news comes after Phase 3 clinical trial results for donanemab, presented at the Alzheimer’s Association International Conference in July 2023, showed that the drug significantly slowed cognitive and functional decline for amyloid-positive early symptomatic Alzheimer’s disease patients.