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Home » US FDA adcom supports Leqembi for full approval
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US FDA adcom supports Leqembi for full approval

June 9, 2023
By Karen Carey
Eisai Co. Ltd. and Biogen Inc.’s Leqembi (lecanemab) gained the support of the U.S. FDA’s Peripheral and Central Nervous System Drugs Advisory Committee (adcom) in a 6-0 vote on June 9, as panel members unanimously agreed that the results of the phase III Clarity trial verified the clinical benefit in the treatment of Alzheimer’s disease. The FDA does not have to follow the adcom’s recommendation, but it often does. The PDUFA date for the supplemental NDA is July 6.
BioWorld Regulatory Neurology/psychiatric U.S. FDA

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