Role of Aducanumab in the Treatment of Alzheimer’s Disease: Challenges and Opportunities
Miguel Vaz,1 Vítor Silva,1 Cristina Monteiro,2 Samuel Silvestre1,3 1CICS-UBI - Health Sciences Research Centre, Faculty of Health Sciences, University of Beira Interior, Covilhã, 6200-506, Portugal; 2UFBI – Pharmacovigilance Unit of Beira Interior, University of Beira Interior, Covilhã, 6200-506, Po...
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| Format: | Article |
| Language: | English |
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Dove Medical Press
2022-05-01
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| Series: | Clinical Interventions in Aging |
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| Online Access: | https://www.dovepress.com/role-of-aducanumab-in-the-treatment-of-alzheimers-disease-challenges-a-peer-reviewed-fulltext-article-CIA |
| _version_ | 1818211709448355840 |
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| author | Vaz M Silva V Monteiro C Silvestre S |
| author_facet | Vaz M Silva V Monteiro C Silvestre S |
| author_sort | Vaz M |
| collection | DOAJ |
| description | Miguel Vaz,1 Vítor Silva,1 Cristina Monteiro,2 Samuel Silvestre1,3 1CICS-UBI - Health Sciences Research Centre, Faculty of Health Sciences, University of Beira Interior, Covilhã, 6200-506, Portugal; 2UFBI – Pharmacovigilance Unit of Beira Interior, University of Beira Interior, Covilhã, 6200-506, Portugal; 3CNC- Center for Neuroscience and Cell Biology, University of Coimbra, Coimbra, 3004-517, PortugalCorrespondence: Miguel Vaz; Samuel Silvestre, CICS-UBI - Health Sciences Research Centre, Faculty of Health Sciences, University of Beira Interior, Av. Infante D. Henrique, Covilhã, 6200-506, Portugal, Tel +351 275 329002/3, Fax +351 275 329099, Email miguel.vaz@ubi.pt; sms@ubi.ptAbstract: Aducanumab is a monoclonal antibody selective for amyloid β (Aβ) aggregates. In June 2021, aducanumab became the first drug underlying the pathophysiology of Alzheimer’s disease (AD) approved by the US Food and Drug Administration (FDA), under the accelerated approval pathway. The decision was based on the ability of aducanumab to remove Aβ plaques, without any evidence that the Aβ clearance is correlated with less cognitive or functional decline. This decision has generated a considerable debate in the scientific community, especially because the results from the two Phase 3 trials, EMERGE and ENGAGE, were divergent and, even after the post hoc analysis, the data were insufficient to prove aducanumab efficacy. Moreover, some researchers think that this approval will be an obstacle to the progress and also demonstrated concerns about aducanumab cost and its safety profile. The European Medicines Agency’s rejection of aducanumab in December 2021 just brought more controversy over FDA’s decision. Now, Biogen is designing the FDA’s required confirmatory study, named ENVISION, which should be complete in 2026. Despite the controversy, the aducanumab showed to affect downstream tau pathology, which could open doors for a combination therapy approach for AD (anti-tau and anti-amyloid drug). This review summarizes the clinical development of aducanumab until regulatory agencies’ decisions, the available trials data and the controversy over aducanumab approval for AD.Keywords: anti-Aβ monoclonal antibody, ARIA, clinical trials, European Medicines Agency, Food and Drug Administration, tau protein |
| first_indexed | 2024-12-12T05:36:49Z |
| format | Article |
| id | doaj.art-8e110570ccd14235a18cef2298729fc6 |
| institution | Directory Open Access Journal |
| issn | 1178-1998 |
| language | English |
| last_indexed | 2024-12-12T05:36:49Z |
| publishDate | 2022-05-01 |
| publisher | Dove Medical Press |
| record_format | Article |
| series | Clinical Interventions in Aging |
| spelling | doaj.art-8e110570ccd14235a18cef2298729fc62022-12-22T00:36:06ZengDove Medical PressClinical Interventions in Aging1178-19982022-05-01Volume 1779781075365Role of Aducanumab in the Treatment of Alzheimer’s Disease: Challenges and OpportunitiesVaz MSilva VMonteiro CSilvestre SMiguel Vaz,1 Vítor Silva,1 Cristina Monteiro,2 Samuel Silvestre1,3 1CICS-UBI - Health Sciences Research Centre, Faculty of Health Sciences, University of Beira Interior, Covilhã, 6200-506, Portugal; 2UFBI – Pharmacovigilance Unit of Beira Interior, University of Beira Interior, Covilhã, 6200-506, Portugal; 3CNC- Center for Neuroscience and Cell Biology, University of Coimbra, Coimbra, 3004-517, PortugalCorrespondence: Miguel Vaz; Samuel Silvestre, CICS-UBI - Health Sciences Research Centre, Faculty of Health Sciences, University of Beira Interior, Av. Infante D. Henrique, Covilhã, 6200-506, Portugal, Tel +351 275 329002/3, Fax +351 275 329099, Email miguel.vaz@ubi.pt; sms@ubi.ptAbstract: Aducanumab is a monoclonal antibody selective for amyloid β (Aβ) aggregates. In June 2021, aducanumab became the first drug underlying the pathophysiology of Alzheimer’s disease (AD) approved by the US Food and Drug Administration (FDA), under the accelerated approval pathway. The decision was based on the ability of aducanumab to remove Aβ plaques, without any evidence that the Aβ clearance is correlated with less cognitive or functional decline. This decision has generated a considerable debate in the scientific community, especially because the results from the two Phase 3 trials, EMERGE and ENGAGE, were divergent and, even after the post hoc analysis, the data were insufficient to prove aducanumab efficacy. Moreover, some researchers think that this approval will be an obstacle to the progress and also demonstrated concerns about aducanumab cost and its safety profile. The European Medicines Agency’s rejection of aducanumab in December 2021 just brought more controversy over FDA’s decision. Now, Biogen is designing the FDA’s required confirmatory study, named ENVISION, which should be complete in 2026. Despite the controversy, the aducanumab showed to affect downstream tau pathology, which could open doors for a combination therapy approach for AD (anti-tau and anti-amyloid drug). This review summarizes the clinical development of aducanumab until regulatory agencies’ decisions, the available trials data and the controversy over aducanumab approval for AD.Keywords: anti-Aβ monoclonal antibody, ARIA, clinical trials, European Medicines Agency, Food and Drug Administration, tau proteinhttps://www.dovepress.com/role-of-aducanumab-in-the-treatment-of-alzheimers-disease-challenges-a-peer-reviewed-fulltext-article-CIAanti-aβ monoclonal antibodyariaclinical trialseuropean medicines agencyfood and drug administrationtau protein. |
| spellingShingle | Vaz M Silva V Monteiro C Silvestre S Role of Aducanumab in the Treatment of Alzheimer’s Disease: Challenges and Opportunities Clinical Interventions in Aging anti-aβ monoclonal antibody aria clinical trials european medicines agency food and drug administration tau protein. |
| title | Role of Aducanumab in the Treatment of Alzheimer’s Disease: Challenges and Opportunities |
| title_full | Role of Aducanumab in the Treatment of Alzheimer’s Disease: Challenges and Opportunities |
| title_fullStr | Role of Aducanumab in the Treatment of Alzheimer’s Disease: Challenges and Opportunities |
| title_full_unstemmed | Role of Aducanumab in the Treatment of Alzheimer’s Disease: Challenges and Opportunities |
| title_short | Role of Aducanumab in the Treatment of Alzheimer’s Disease: Challenges and Opportunities |
| title_sort | role of aducanumab in the treatment of alzheimer rsquo s disease challenges and opportunities |
| topic | anti-aβ monoclonal antibody aria clinical trials european medicines agency food and drug administration tau protein. |
| url | https://www.dovepress.com/role-of-aducanumab-in-the-treatment-of-alzheimers-disease-challenges-a-peer-reviewed-fulltext-article-CIA |
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