Adcomm Votes Unanimously for Lilly’s Alzheimer’s Treatment Donanemab

FDA sign_iStock, JHVEPhoto

Pictured: FDA sign at its office in Washington, DC/iStock, JHVEPhoto

On Monday, the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee voted unanimously, 11 to zero, in favor of Eli Lilly’s Alzheimer’s treatment, donanemab. The group of advisors not only determined donanemab to be an effective treatment for Alzheimer’s disease with mild cognitive impairment and mild dementia, but that the benefits outweigh the risks.

Kathleen Poston, the director of the neurological science at Stanford’s Movement Disorders Center, voted yes because she felt the clinical data across subgroups and the biomarker data were “convincing of the effect,” she said in the adcomm vote.  

When Biogen’s Leqembi was approved last year, it became the first real treatment option to target a suspected underlying cause of the disease: amyloid beta plaques. The FDA had previously granted accelerated approval to Eisai and…
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