Can we learn lessons from the FDA’s approval of aducanumab?

On 7 June 2021, aducanumab was granted accelerated approval for the treatment of Alzheimer disease by the FDA on the basis of amyloid-lowering effects considered reasonably likely to confer clinical benefit. This decision makes aducanumab the first new drug to be approved for the treatment of AD since 2003 and the first drug to ever be approved for modification of the course of AD. Here, we reflect on events leading to the FDA's decision on 7 June 2021 and consider whether any lessons can be learned for the field.