FDA Approves Alzheimer’s Drug Despite Expert Panel’s Objections

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Sumary of FDA Approves Alzheimer’s Drug Despite Expert Panel’s Objections:

  • Food and Drug Administration on Monday, despite opposition from the agency’s own independent advisory committee and some experts who said there wasn’t enough proof the drug could actually help patients..
  • In clinical trials, aducanumab (Aduhelm) showed a 22% reduction in the development of thinking and memory problems associated with Alzheimer’s disease, according to a statement from the Alzheimer’s Association..
  • However, Monday’s approval flies in the face of a near-unanimous recommendation against use of the drug by the FDA’s own independent advisory committee, as well the objections of a number of prominent Alzheimer’s experts..
  • Back in November, 10 of 11 members on an FDA advisory panel voted against approval, even after hearing a presentation by the agency’s director of neuroscience arguing there is “strong”.
  • Caleb Alexander, an FDA advisory committee member with the Johns Hopkins Bloomberg School of Public Health in Baltimore, told the Times….

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