Approval of Aducanumab for Alzheimer Disease-The FDA's Perspective

JAMA Intern Med. 2021 Oct 1;181(10):1276-1278. doi: 10.1001/jamainternmed.2021.4607.
No abstract available

MeSH terms

  • Alzheimer Disease* / diagnosis
  • Alzheimer Disease* / drug therapy
  • Amyloid beta-Peptides / antagonists & inhibitors
  • Antibodies, Monoclonal, Humanized* / administration & dosage
  • Antibodies, Monoclonal, Humanized* / adverse effects
  • Antibodies, Monoclonal, Humanized* / economics
  • Brain* / diagnostic imaging
  • Brain* / pathology
  • Decision Making
  • Dose-Response Relationship, Drug*
  • Drug Approval / methods
  • Humans
  • Infusions, Intravenous / methods
  • Magnetic Resonance Imaging / methods
  • Nootropic Agents / administration & dosage
  • Nootropic Agents / adverse effects
  • Nootropic Agents / economics
  • Plaque, Amyloid / diagnostic imaging*
  • Positron-Emission Tomography / methods
  • Product Surveillance, Postmarketing
  • Randomized Controlled Trials as Topic / methods
  • Treatment Outcome
  • United States

Substances

  • Amyloid beta-Peptides
  • Antibodies, Monoclonal, Humanized
  • Nootropic Agents
  • aducanumab