The FDA’s approval of aducanumab as a treatment for Alzheimer Disease in June, 2021 was controversial. There were a number of known side effects and new information from clinical trials reveals possible serious consequences. Acucanumab was developed by Biogen and is being sold by Acumen as a $56,000-a-year treatment for Alzheimer’s.
According to an article in Nature1 the FDA’s advisory committee of outside experts and Alzheimer’s specialists recommended waiting on aducanmab approval, but it was fast-tracked and approved anyway. The committee reported that benefits were unclear and that there were serious side effects. Although Acumen claimed that aducanumab is likely to provide cognitive improvement, the statistics may not back that up. Unsurprisingly, the pharmaceutical company, Acumen, filed papers for a public stock offering immediately after approval.
New information reported by the New York Times2 reveals that recently published safety data demonstrates that 41.3% of people in key clinical trials experienced asymptomatic brain swelling or bleeding – a condition known as ARIA (amyloid related imaging abnormalities) – 425 of 1029 patients, with serious side effects for 1.4% of patients.3
And in September, a 75-year old woman receiving the treatment in a clinical trial died.[Ibid. Belluck. (2021).] The adverse incident is being investigated by both the FDA and Biogen, but it is thought to be the result of brain swelling.
We feel that the best treatment for neurodegenerative conditions like Alzheimer’s is prevention, prevention, prevention. There is plenty of research to demonstrate that exercise, proper nutrition, mental activity, and reduced stress are actually measurable ways to reduce risk.
For more information, see the Alzheimer’s section on our website. We’ve also written a book discussing prevention points, and herbal supplements, Natural Brain Support: Your Guide to Preventing and Treating Alzheimer’s.
- Mullard A. (2021). Controversial Alzheimer’s drug approval could affect other diseases. Nature. Jun:595, 162-163. ↩
- Belluck P. (2021). Concerns Grow Over Safety of Aduhelm After Death of Patient Who Got the Drug. New York Times, Nov 22. ↩
- Salloway S, Chalkias S, Barkhof F, Burkett P, Barakos J. (2021). Amyloid-Related Imaging Abnormalities in 2 Phase 3 Studies Evaluating Aducanumab in Patients with Early Alzheimer Disease. JAMA Neurology. Nov 22. ↩
