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

23 Jun 2021

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 multiple offices and centers...