Trial data shows new FDA-approved Alzheimer's drug #lecanemab can lead to 'brain shrinkage'.
Advocacy groups celebrate its approval but critics question if the benefits outweigh harms & object to FDA decision without input from advisory committee.
maryannedemasi.substack.com/p/alzheimers-d… @RxRegA
Advocacy groups celebrate its approval but critics question if the benefits outweigh harms & object to FDA decision without input from advisory committee.
maryannedemasi.substack.com/p/alzheimers-d… @RxRegA
No FDA advisory panel?
"The FDA once again has shown a lack of concern for the public, patients, and healthcare providers. Convening its advisory panel would have helped reassure everyone that the FDA’s decision was scientifically sound and transparent,” said @woodymatters
"The FDA once again has shown a lack of concern for the public, patients, and healthcare providers. Convening its advisory panel would have helped reassure everyone that the FDA’s decision was scientifically sound and transparent,” said @woodymatters
FDA 'accelerated' approval of #lecanumab accepted lower burden of proof for benefit e.g. showing lower amyloid protein in brain (surrogate marker) instead of showing a clinically meaningful benefit for person with Alzheimer's disease on a day-to-day basis.
#Lecanemab = Brain Shrinkage?
“The observation of brain shrinkage is worrisome because, in the absence of compelling evidence to the contrary, it suggests a potential worsening of degenerative changes in the brains of people with Alzheimer’s disease,” @MadhavThambiset in STAT.
“The observation of brain shrinkage is worrisome because, in the absence of compelling evidence to the contrary, it suggests a potential worsening of degenerative changes in the brains of people with Alzheimer’s disease,” @MadhavThambiset in STAT.
It it time to retire the "amyloid hypothesis" of Alzheimer's disease?
“After so many years, I’m fed up with the exclusive focus on the amyloid theory to the exclusion of other research theories, it’s a disservice to people with Alzheimer's and their families,” said @furlinil
“After so many years, I’m fed up with the exclusive focus on the amyloid theory to the exclusion of other research theories, it’s a disservice to people with Alzheimer's and their families,” said @furlinil
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