FDA Delays Decision on Lilly’s Alzheimer’s Drug Donanemab

The Food and Drug Administration (FDA) has extended its review period for Eli Lilly’s Alzheimer’s drug donanemab, diverging from its original timeline. Lilly sought FDA approval in July following a late-stage trial showing a 29% reduction in Alzheimer’s progression over 18 months, echoing results of Leqembi, another Alzheimer’s drug approved by the FDA.

Originally scheduled for a decision early next week, the FDA now seeks further advice from its independent advisory committee, focusing on safety and efficacy concerns of donanemab, as informed to Lilly. No date for the committee meeting has been set yet.

Donanemab’s potential approval would mark it as the third of a new class of Alzheimer’s treatments in the U.S., joining Eisai and Biogen’s Leqembi and Biogen’s Aduhelm. These monoclonal antibody drugs target amyloid in the brain, a key Alzheimer’s marker. However, their clinical benefits are modest and concerns over severe side effects like brain swelling and bleeding persist.

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Aduhelm, particularly, faced controversy since its accelerated approval in 2021 despite an FDA advisory committee’s rejection due to insufficient efficacy evidence. An 18-month congressional probe later criticized the FDA’s approval process for Aduhelm as flawed and irregular, intensifying scrutiny on the agency.

Additionally, Aduhelm’s initial annual cost of $56,000, later halved, sparked concerns over Medicare premium hikes. Under accelerated approval, it was covered by Medicare only in a clinical trial setting. However, the drug has since been withdrawn from the market without full FDA approval. This backdrop heightens attention on the FDA’s decision-making process for Alzheimer’s treatments like donanemab.