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As Aducanumab’s US FDA Review Progressed, Support Grew For Accelerated Approval

 
• By Sue Sutter

Use of expedited pathway for Biogen's Alzheimer's drug was discussed at a center director briefing in late April, where it garnered backing from several senior CDER officials, as well as CBER director Peter Marks and OCE director Richard Pazdur.

Momentum
The idea of accelerated approval gained momentum late in Aduhelm's regulatory review. • Source: Alamy

In November 2020, Biogen, Inc.'s Aduhelm (aducanumab-avwa) exited a US Food and Drug Administration advisory committee review with little to no support from the agency's external experts for regular approval, despite a strong endorsement by the FDA clinical review team and Office of Neuroscience leadership.

However, as the Alzheimer’s drug’s tangled regulatory review progressed, it gained backing for accelerated approval across

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