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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...

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• By Sue Sutter

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