Aducanumab and Accelerated Approval: Where Do We Go From Here?

When the US Food and Drug Administration (FDA) approved aducanumab (Aduhelm) as a treatment for Alzheimer's disease in June 2021, it sent shockwaves across the healthcare system for two main reasons: the decision itself and the process leading to the decision. The fallout from this decision in the past year has led to calls for changes to the accelerated approval pathway.

Automated summary

The FDA's approval of aducanumab as a treatment for Alzheimer's disease in June 2021 caused significant impact and led to calls for changes to the accelerated approval pathway.