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Aduhelm's Journey To Accelerated Approval: Finding Buried Treasure In Uncharted Waters

 
• By Sue Sutter

The Alzheimer’s drug’s regulatory voyage to accelerated approval was circuitous – a destination briefly visited but one that reappeared on the horizon only as time ticked down on the application’s user fee goal date.  

treasure map
X marks the spot of accelerated approval on Biogen's treasure map. • Source: Alamy

The regulatory journey to accelerated approval for Biogen, Inc. and Eisai Co., Ltd.’s Alzheimer’s drug Aduhelm (aducanumab-avwa) was circuitous – a destination briefly visited but one that reappeared on the horizon only as time ticked down on the application’s 7 June user fee goal date.

US Food and Drug Administration review documents show that as early as December 2014, there was discussion with Biogen about how to prospectively incorporate biomarkers, such as amyloid imaging, into the Phase III program

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