Article ; Online: FDA's dilemma with the aducanumab approval: public pressure and hope, surrogate markers and efficacy, and possible next steps.
BMJ evidence-based medicine
2022 Volume 28, Issue 2, Page(s) 78–82
Abstract: Accelerating Food and Drug Administration (FDA) product approval to market based on surrogate markers in the absence of proven efficacy creates a risk of adverse outcomes for affected patients, even in response to a life-threatening condition, such as in ...
| Abstract | Accelerating Food and Drug Administration (FDA) product approval to market based on surrogate markers in the absence of proven efficacy creates a risk of adverse outcomes for affected patients, even in response to a life-threatening condition, such as in this case, Alzheimer's disease. FDA's recent unexpected approval of aducanumab, despite the unified opposition of its own highly respected advisory committee after the early termination of two efficacy trials, creates the potential risk of adverse effects and lack of clinical efficacy at very high costs. In view of these concerns, a thorough review of the issues and pressures that led to this decision is worth the careful consideration of the clinical and scientific communities with regard to whether this approval represents a calculated and balanced compassionate decision versus a disturbing precedent. |
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| MeSH term(s) | Humans ; Biomarkers ; Drug Approval ; United States Food and Drug Administration ; Antibodies, Monoclonal, Humanized ; Early Termination of Clinical Trials ; Advisory Committees |
| Chemical Substances | aducanumab (105J35OE21) ; Biomarkers ; Antibodies, Monoclonal, Humanized |
| Language | English |
| Publishing date | 2022-04-21 |
| Publishing country | England |
| Document type | Journal Article |
| ISSN | 2515-4478 |
| ISSN (online) | 2515-4478 |
| DOI | 10.1136/bmjebm-2022-111914 |
| Database | MEDical Literature Analysis and Retrieval System OnLINE |
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