Posted by Michael Wonder on 25 Jul 2021
Patient advocacy organisations and FDA drug approval: lessons from Aduhelm
23 July 2021 - In the wake of last month’s controversial FDA approval of Biogen’s Aduhelm, Alzheimer’s Association CEO Harry Johns condemned the “negative voices” concentrating on the flaws in the FDA’s approval as “not pro-patient.”
The Alzheimer’s Association wasn’t the only patient advocacy organisation applauding the FDA’s questionable decision, which was based on changes in a surrogate endpoint for Alzheimer’s disease — reduction of amyloid in the brain, an outcome the FDA had previously rejected and that dozens of previous studies had failed to associate with better dementia outcomes.
