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Published 20:21 IST, June 11th 2024

US FDA Advisory Committee Unanimously Backs Eli Lilly's Alzheimer's Drug

The Alzheimer's drug 'donanemab' by Eli Lily received approval from the US Food and Drug Administration's committee of independent advisors.

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Following thorough deliberation on the cost-benefit analysis, an independent advisory committee to the US Food and Drug Administration (FDA) unanimously ruled in favor of Eli Lilly's Alzheimer’s drug, Donanemab, citing its modest benefits outweigh potential risks.

The vote paves the way for a final-word  by the federal agnecy of the Department of Health and Human Services on the treatment, which initially had been expected earlier this year before the agency called for the meeting so its independent panel of experts could weigh in.

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What can be expected of Donanemab?

Eli Lilly’s Donanemab is a monoclonal antibody that focuses on amyloid beta protein plaques in the brain, a characteristic feature of Alzheimer’s disease that can be seen on imaging. Similar amyloid-fighting drugs, Leqembi and Biogen, were approved by FDA last year.

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What do the Phase III trial results indicate?

Phase III clinical trials revealed a 35.1 per cent cognitive decline reduction in early Alzheimer’s patients over 76 weeks with Donanemab. The study involved 1,736 participants, 860 of whom received the infusion every four weeks until amyloid beta plaque clearance.

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While studies indicate slightly higher adverse events compared to Lecanemab, Donanemab's notable side effects include infusion-related reactions and amyloid-related imaging abnormalities (ARIA) such as brain swelling or bleeding, with 24 per cent experiencing ARIA-related swelling and 19.7 per cent experiencing ARIA-related bleeds. Three treatment-related deaths were broutgh to light, as per media reports. 

Concerns arise regarding the cost implications of implementing Donanemab, especially given its significant impact on early-stage Alzheimer’s. Expertise and validated tools at the primary care level are deemed necessary, as highlighted in a JAMA editorial, adding to the financial burden.
 

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20:21 IST, June 11th 2024