In episode 483, James and Mike invite Tina to the podcast to talk about the aducanumab (Aduhelm) FDA approval story. We look at all the latest evidence, we talk about how people analyzed the data, whether or not the findings were clinically important, the side effects and finally the cost. And no matter how we looked at it we were still puzzled it got FDA approval. What do you think?
1) Effect of reductions in amyloid levels on cognitive change in randomized trials: instrumental variable meta-analysis.
BMJ 2021; 372 doi: https://doi.org/10.1136/bmj.n156 (Published 25 February 2021)
2) Failure to demonstrate efficacy of aducanumab: An analysis of the EMERGE and ENGAGE trials as reported by Biogen, December 2019
Alzheimers Dement. 2021 Apr;17(4):696-701. doi: 10.1002/alz.12213. Epub 2020 Nov 1.
3) Institute for Clinical and Economic Review
Aducanumab for Alzheimer’s Disease: Effectiveness and Value