FDA approves Aduhelm (aducanumab) using the accelerated approval pathway used for drugs treating serious or life-threatening illness that provide a meaningful therapeutic advantage over existing treatments. The drug is shown to have an effect and reasonably likely to have a clinical benefit to patients, yet there remains some uncertainty about the drug’s true clinical benefit.

https://www.fda.gov/drugs/news-events-human-drugs/fdas-decision-approve-new-treatment-alzheimers-disease

https://www.nia.nih.gov/news/nia-statement-fda-approval-aducanumab-alzheimers-disease