Discover and read the best of Twitter Threads about #lecanumab
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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.
