Petri Dish

Ep. 105 Alzheimer's Disease Pt 2: FDA Approval

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I don't know if y'all have heard or not, but a month ago the FDA approved a drug for the treatment of Alzheimer's Disease, the first one in a couple of decades. This approval was met with the resignation of some members of the FDA's own scientific advisory group, which had recommended that the drug not be approved. What is going on here? Let's get into the science behind this drug, how the approval process works, and what this whole situation means!

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References:

  • https://www.fda.gov/drugs/news-events-human-drugs/fdas-decision-approve-new-treatment-alzheimers-disease
  • https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-updates-label-biogens-alzheimers-drug-specify-disease-stage-2021-07-08/
  • https://journals.lww.com/neurotodayonline/Fulltext/2021/07080/Dementia_Experts_on_Why_the_FDA_Approval_of.3.aspx
  • https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/761178Orig1s000ClinPharm_Redacted.pdf
  • https://mind.uci.edu/apoe4-carriers-show-early-breakdown-to-blood-brain-barrier-before-cognitive-impairment/
  • https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/761178Orig1s000MedR_Redacted.pdf
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