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An About Face As Biogen Says It Will File Aducanumab In Alzheimer’s

 
• By Mandy Jackson

Biogen surprised investors with news that it will file aducanumab with the FDA based on data from more patients treated at the highest dose than in the interim futility analysis that led to termination of two Phase III studies in March.

Profile of a human head with a colorful symbol of neurons in the brain
Biogen revived once-discontinued aducanumab and plans to file for US FDA approval. • Source: Shutterstock

Biogen’s unexpected decision to pursue US Food and Drug Administration approval for its previously discontinued amyloid-targeting biologic aducanumab in Alzheimer’s disease was met with skepticism given the surprising nature of the turnaround. 

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