Aducanumab na Doença de Alzheimer: Percurso e Perspetiva
Palavras-chave:Anticorpos Monoclonais Humanizados, Doença de Alzheimer/tratamento farmacológico
Arndt, J. W. et al. Structural and kinetic basis for the selectivity of aducanumab for aggregated forms of amyloid-β. Sci Rep 8, 6412 (2018). DOI: https://doi.org/10.1038/s41598-018-24501-0
Sevigny, J. et al. The antibody aducanumab reduces Aβ plaques in Alzheimer’s disease. Nature 537, 50–56 (2016). DOI: https://doi.org/10.1038/nature19323
Knopman, D. S., Jones, D. T. & Greicius, M. D. Failure to demonstrate efficacy of aducanumab: An analysis of the EMERGE and ENGAGE trials as reported by Biogen, December 2019. Alzheimer’s & Dementia 17, 696–701 (2021). DOI: https://doi.org/10.1002/alz.12213
Commissioner, O. of the. FDA Grants Accelerated Approval for Alzheimer’s Drug. FDA https://www.fda.gov/news-events/press-announcements/fda-grants-accelerated-approval-alzheimers-drug (2021).
VandeVrede, L. et al. Symptomatic amyloid‐related imaging abnormalities in an APOE ε4/ε4 patient treated with aducanumab. Alzheimers Dement (Amst) 12, e12101 (2020). DOI: https://doi.org/10.1002/dad2.12101
ICER Issues Statement on the FDA’s Approval of Aducanumab for Alzheimer’s Disease. ICER https://icer.org/news-insights/press-releases/icer-issues-statement-on-the-fdas-approval-of-aducanumab-for-alzheimers-disease/.
Lin GA, Whittington MD, Synnott PG, McKenna A, Campbell J, Pearson & SD, Rind DM. Aducanumab for Alzheimer’s Disease: Effectiveness and Value; Final Evidence Report and Meeting Summary. (2021).
Biogen to Present Data from ADUHELM and Alzheimer’s Disease Portfolio at 2021 Alzheimer’s Association International Conference | Biogen. https://investors.biogen.com/news-releases/news-release-details/biogen-present-data-aduhelm-and-alzheimers-disease-portfolio.
Update on Regulatory Review of Aducanumab in the European Union | Biogen. https://investors.biogen.com/news-releases/news-release-details/update-regulatory-review-aducanumab-european-union.
European Medicines Agency. Refusal of the marketing authorisation for Aduhelm (aducanumab). (2021).