The FDA’s approval of aducanumab in Alzheimer’s disease
Jul 2021
On 7 June 2021 the US Food and Drug Administration (FDA) approved the first new drug for Alzheimer’s disease in 18 years, aducanumab. It is also the first approved drug that attempts to treat a possible cause of the neurodegenerative disease, rather than just the symptoms. Its approval was based on findings from the ENGAGE and EMERGE clinical trials and has led to a broad debate. Here we have selected a range of articles that aim to cover this many-sided discourse:
Approval reaction
- Landmark Alzheimer’s drug approval confounds research community:
https://www.nature.com/articles/d41586-021-01546-2 - Expert reaction to FDA approval of aducanumab (Aduhelm) for Alzheimer’s disease, through the Accelerated Approval pathway:
https://www.sciencemediacentre.org/expert-reaction-to-fda-approval-of-aducanumab-aduhelm-for-alzheimers-disease-through-the-accelerated-approval-pathway/?cli_action=1623232862.507 - 3 big questions to ask after FDA’s historic Alzheimer’s drug approval:
https://www.advisory.com/en/daily-briefing/2021/06/07/aducanumab - Alzheimer Europe welcomes FDA decision to approve aducanumab:
https://www.alzheimer-europe.org/News/Science-watch/Monday-07-June-2021-Alzheimer-Europe-welcomes-FDA-decision-to-approve-aducanumab
For more information
- Brain Health Scotland FAQ:
https://www.brainhealth.scot/aducanumab - ENGAGE and EMERGE: Truth and consequences?:
https://alz-journals.onlinelibrary.wiley.com/doi/10.1002/alz.12286 - ENGAGE:
https://clinicaltrials.gov/ct2/show/study/NCT02477800
