FDA adcomm votes unanimously in favor of full approval for Eisai's new Alzheimer's drug

Zachary Brennan

Senior Editor

The FDA’s Peripheral and Central Nervous System Drugs Advisory Committee on Friday voted 6-0 in favor of fully approving Eisai and Biogen’s Alzheimer’s drug Leqembi (lecanemab), which first won an accelerated approval in January.

The full approval, expected on or before July 6, would open the door to wider insurance and Medicare coverage for those with mild cognitive impairment or mild dementia and confirmed presence of amyloid beta pathology but who could not or do not want to pay the $26,500 per year list price.

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FDA adcomm votes unanimously in favor of full approval for Eisai's new Alzheimer's drug

Zachary Brennan

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Unlock this article instantly by becoming a free subscriber.

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FDA adcomm votes unanimously in favor of full approval for Eisai's new Alzheimer's drug

FDA rolls out long-awaited proposal to overhaul diagnostics regulation

Despite a summer of blockbuster rounds, biotech funding is on track to level off at pre-pandemic norms

How academic centers are trying to keep their promising drug discoveries out of the ‘valley of death’

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In the race to get type 1 patients off insulin, focus turns to cell transplants and insulin-producing stem cells

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