"Setbacks in Alzheimer's Drug Approval: Understanding the Delay of a Promising Treatment"

The much-hyped Alzheimer's drug, donanemab, faces approval delays as the FDA requests further scrutiny of its safety and efficacy. While the drug showed a 35% cognitive and functional decline reduction in a clinical trial, concerns about potential side effects, including brain swelling and hemorrhaging, have arisen. Experts question the clinical relevance of the drug's effects and its high cost, while emphasizing the need for broader approaches to tackling Alzheimer's, including addressing modifiable risk factors and societal structures.