FDA's dilemma with the aducanumab approval : public pressure and hope, surrogate markers and efficacy, and possible next steps
© Author(s) (or their employer(s)) 2023. No commercial re-use. See rights and permissions. Published by BMJ..
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.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2023 |
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| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:28 |
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| Enthalten in: |
BMJ evidence-based medicine - 28(2023), 2 vom: 21. Apr., Seite 78-82 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Rizk, John G [VerfasserIn] |
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| Links: |
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| Themen: |
105J35OE21 |
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| Anmerkungen: |
Date Completed 29.03.2023 Date Revised 29.03.2023 published: Print-Electronic Citation Status MEDLINE |
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| doi: |
10.1136/bmjebm-2022-111914 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM339801603 |
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| 520 | |a © Author(s) (or their employer(s)) 2023. No commercial re-use. See rights and permissions. Published by BMJ. | ||
| 520 | |a 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 | ||
| 650 | 4 | |a Journal Article | |
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| 650 | 4 | |a Evidence-Based Practice | |
| 650 | 4 | |a Nervous System Diseases | |
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