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Is Aducanumab for LMICs? Promises and Challenges

Aducanumab, a human monoclonal antibody, was approved in June of 2021 as the first disease-modifying treatment for Alzheimer’s disease by the United States Food and Drug Administration (U.S. FDA). A substantial proportion of patients with Alzheimer’s disease live in low- and middle-income countries...

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Autores principales: Gunawardena, Illangage P. C., Retinasamy, Thaarvena, Shaikh, Mohd. Farooq
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8615623/
https://www.ncbi.nlm.nih.gov/pubmed/34827546
http://dx.doi.org/10.3390/brainsci11111547
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author Gunawardena, Illangage P. C.
Retinasamy, Thaarvena
Shaikh, Mohd. Farooq
author_facet Gunawardena, Illangage P. C.
Retinasamy, Thaarvena
Shaikh, Mohd. Farooq
author_sort Gunawardena, Illangage P. C.
collection PubMed
description Aducanumab, a human monoclonal antibody, was approved in June of 2021 as the first disease-modifying treatment for Alzheimer’s disease by the United States Food and Drug Administration (U.S. FDA). A substantial proportion of patients with Alzheimer’s disease live in low- and middle-income countries (LMICs), and the debilitating effects of this disease exerts burdens on patients and caregivers in addition to the significant economic strains many nations bear. While the advantages of a disease-modifying therapy are clear in delaying the progression of disease to improve patient outcomes, aducanumab’s approval by the U.S. FDA was met with controversy for a plethora of reasons. This paper will provide precursory insights into aducanumab’s role, appropriateness, and cost-effectiveness in low- and middle-income countries. We extend some of the controversies associated with aducanumab, including the contradicting evidence from the two trials (EMERGE and ENGAGE) and the resources required to deliver the treatment safely and effectively to patients, among other key considerations.
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spelling pubmed-86156232021-11-26 Is Aducanumab for LMICs? Promises and Challenges Gunawardena, Illangage P. C. Retinasamy, Thaarvena Shaikh, Mohd. Farooq Brain Sci Review Aducanumab, a human monoclonal antibody, was approved in June of 2021 as the first disease-modifying treatment for Alzheimer’s disease by the United States Food and Drug Administration (U.S. FDA). A substantial proportion of patients with Alzheimer’s disease live in low- and middle-income countries (LMICs), and the debilitating effects of this disease exerts burdens on patients and caregivers in addition to the significant economic strains many nations bear. While the advantages of a disease-modifying therapy are clear in delaying the progression of disease to improve patient outcomes, aducanumab’s approval by the U.S. FDA was met with controversy for a plethora of reasons. This paper will provide precursory insights into aducanumab’s role, appropriateness, and cost-effectiveness in low- and middle-income countries. We extend some of the controversies associated with aducanumab, including the contradicting evidence from the two trials (EMERGE and ENGAGE) and the resources required to deliver the treatment safely and effectively to patients, among other key considerations. MDPI 2021-11-22 /pmc/articles/PMC8615623/ /pubmed/34827546 http://dx.doi.org/10.3390/brainsci11111547 Text en © 2021 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Review
Gunawardena, Illangage P. C.
Retinasamy, Thaarvena
Shaikh, Mohd. Farooq
Is Aducanumab for LMICs? Promises and Challenges
title Is Aducanumab for LMICs? Promises and Challenges
title_full Is Aducanumab for LMICs? Promises and Challenges
title_fullStr Is Aducanumab for LMICs? Promises and Challenges
title_full_unstemmed Is Aducanumab for LMICs? Promises and Challenges
title_short Is Aducanumab for LMICs? Promises and Challenges
title_sort is aducanumab for lmics? promises and challenges
topic Review
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8615623/
https://www.ncbi.nlm.nih.gov/pubmed/34827546
http://dx.doi.org/10.3390/brainsci11111547
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