The US Food and Drug Administration (FDA) will hold an advisory committee (adcomm on Eisai and Biogen’s Alzheimer’s drug Leqembi by July 6th, according to an announcement from Biogen yesterday, March 5th. This comes a year after an adcomm turned down the application for Aduhelm, another amyloid-targeted Alzheimer’s disease therapy, followed by its controversial accelerated approval.
According to Zachary Brennan, “Leqembi previously won accelerated approval in January for patients with mild cognitive impairment from Alzheimer’s who have confirmed presence of amyloid plaques thought to be a hallmark of the debilitating disease.”
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(Source: Endpoints News, March 6th, 2023)