Public Citizen has urged the Food and Drug Administration (FDA) to launch a formal investigation into the clinical trials of two recently approved Alzheimer's disease drugs, lecanemab (Leqembi) and donanemab (Kisunla). The consumer advocacy group's request centers on concerns regarding the conduct of these trials and the oversight provided by institutional review boards.
The organization's letter to the FDA Commissioner highlights potential issues in the design, execution, or reporting of the clinical trials. Public Citizen is also calling for an examination of the actions of the institutional review boards that were responsible for overseeing these studies.
The request for investigation comes amid ongoing discussions within the medical community regarding the efficacy and safety profiles of lecanemab and donanemab. While these drugs have shown some promise in slowing cognitive decline in early-stage Alzheimer's disease, questions remain about the magnitude of their clinical benefit and the risk of adverse events, such as amyloid-related imaging abnormalities (ARIA).
The FDA's response to Public Citizen's request could have significant implications for the future of Alzheimer's disease drug development and regulatory oversight. A thorough investigation could lead to greater transparency and accountability in clinical trials, potentially influencing the standards for drug approval in this challenging therapeutic area.
