Lessons Learned from Approval of Aducanumab for Alzheimer’s Disease

Lessons Learned from Approval of Aducanumab for Alzheimer’s Disease

2024 January 29; 75: 99–111 | Judith L. Heidebrink, Henry L. Paulson
The article discusses the approval and subsequent failure of aducanumab, a monoclonal antibody targeting beta-amyloid, for the treatment of Alzheimer's disease (AD). Initially hailed as a potential breakthrough, aducanumab's failure to launch highlights the complexities of AD and the need for thorough and transparent regulatory reviews. Key lessons include the limitations of amyloid immunotherapy, the importance of diverse clinical trials, the risks of futility analyses, the need for greater transparency in the approval process, and the challenges of transitioning from clinical trials to real-world treatment. The article emphasizes the importance of restoring public trust and improving future efforts to deliver effective disease-modifying therapies for AD.The article discusses the approval and subsequent failure of aducanumab, a monoclonal antibody targeting beta-amyloid, for the treatment of Alzheimer's disease (AD). Initially hailed as a potential breakthrough, aducanumab's failure to launch highlights the complexities of AD and the need for thorough and transparent regulatory reviews. Key lessons include the limitations of amyloid immunotherapy, the importance of diverse clinical trials, the risks of futility analyses, the need for greater transparency in the approval process, and the challenges of transitioning from clinical trials to real-world treatment. The article emphasizes the importance of restoring public trust and improving future efforts to deliver effective disease-modifying therapies for AD.
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