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BioWorld - Thursday, April 2, 2026
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Home » Donanemab approved: Lilly’s Alzheimer’s drug clears FDA hurdle
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Donanemab approved: Lilly’s Alzheimer’s drug clears FDA hurdle

July 3, 2024
By Jennifer Boggs
Less than a month after the U.S. FDA’s Peripheral and Central Nervous System Drugs Advisory Committee handed down a unanimous vote in favor of Eli Lilly and Co.’s Alzheimer’s disease candidate (AD), donanemab, the agency approved the drug as a once-monthly injection for adults with early symptomatic disease. Branded Kisunla, the beta-amyloid antagonist marks the second approved AD drug that has demonstrated in clinical trials an ability to slow cognitive decline, going up against Leqembi (lecanemab) from Biogen Inc. and Eisai Co. Ltd., which won full approval in July 2023, only six months after nabbing an accelerated nod.
BioWorld Regulatory Neurology/psychiatric Monoclonal antibody U.S. FDA

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