FDA Advisors Unanimously Recommend New Drug for Alzheimer’s Disease

The risk-benefit ratio was deemed ‘acceptable’ even though more adverse events, including deaths, occurred in the drug treatment group.

The U.S. Food and Drug Administration (FDA) in White Oak, Md., on June 5, 2023. Madalina Vasiliu/The Epoch Times

The advisory committee to the U.S. Food and Drug Administration (FDA) unanimously voted on Monday to recommend the approval of donanemab to slow the progression of Alzheimer’s disease.

The Peripheral and Central Nervous System Drugs Advisory Committee was asked to consider whether donanemab is effective for treating Alzheimer’s in those with mild cognitive impairment and mild dementia in the clinical trial population and whether the drug’s benefits outweigh the risks.