Aducanumab: 4 in 10 high dose trial participants experienced brain swelling or bleedingBMJ 2021; 375 doi: https://doi.org/10.1136/bmj.n2975 (Published 01 December 2021) Cite this as: BMJ 2021;375:n2975
- Elisabeth Mahase
- The BMJ
Over 40% of trial participants who had a high dose (10 mg/kg) of the Alzheimer’s disease drug aducanumab experienced brain swelling or bleeding, research has shown.1
Aducanumab, which costs $56 000 (£42 000; €49 000) per patient per year, was controversially approved through the US Food and Drug Administration’s accelerated approval pathway earlier this year.2 The pathway is used when there are uncertainties over efficacy but an expected clinical benefit.
The latest study combined the data from 3285 participants in two international phase III clinical trials—Emerge and Engage—of whom 1029 …