Consensus Statement Regarding the Application of Biogen to Health Canada for Approval of Aducanumab

Alzheimer’s disease is a major cause of morbidity and mortality. Currently, there are no disease-modifying pharmacotherapies for this condition. Aducanumab, an amyloid beta-directed monoclonal antibody that targets aggregated forms of amyloid-beta in the brains of people with Alzheimer’s disease, has raised hopes that such a therapy has been discovered, but its approval by the US Food and Drug Administration has engendered a good deal of controversy. A similar application for approval has been submitted to Health Canada. In response to this, a group of Canadian clinical dementia experts representing a number of organizations, including the Canadian Geriatrics Society, was convened by the Canadian Consortium on Neurodegeneration in Aging (CCNA) to discuss the evidence currently available on this agent and seek consensus on what advice they would offer Health Canada on the application. There was wide-spread agreement that it would be premature for aducanumab to receive approval for the treatment of Alzheimer’s disease. It was also noted that the Canadian health-care system is poorly prepared at this time to deal with a disease-modifying therapeutic with targeting, administration, and monitoring characteristics like aducanumab. In this paper, the consensus reached is presented along with its underlying rationale.

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Aducanumab for Alzheimer's Disease: An Update

Neuroscience Research Notes ◽

10.31117/neuroscirn.v4i2.81 ◽

2021 ◽

Vol 4 (2) ◽

Author(s):

Thaarvena Retinasamy ◽

Mohd. Farooq Shaikh

Keyword(s):

Alzheimer’S Disease ◽

Alzheimer's Disease ◽

Amyloid Beta ◽

Mode Of Action ◽

The Us ◽

The World ◽

Accelerated Approval ◽

Us Fda

The US FDA approved Aducanumab in June 2021 as the first Alzheimer's disease (AD) drug under its accelerated approval pathway. It has given some hope to patients suffering from AD around the world. Aducanumab is an antibody that targets one of the well-known key culprits of this disease, known as amyloid-beta (Aβ). The journey of Aducanumab was bumpy, and there are controversies around the rapid approval of this drug AD treatment. This article highlights the potential of Aducanumab in AD, its mode of action and controversies around it.

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Good problems to have? Policy and societal implications of a disease-modifying therapy for presymptomatic late-onset Alzheimer’s disease

Life Sciences Society and Policy ◽

10.1186/s40504-020-00106-2 ◽

2020 ◽

Vol 16 (1) ◽

Author(s):

Misha Angrist ◽

Anna Yang ◽

Boris Kantor ◽

Ornit Chiba-Falek

Keyword(s):

Alzheimer’S Disease ◽

Alzheimer's Disease ◽

Gene Editing ◽

Late Onset ◽

The United States ◽

Societal Implications ◽

Track Record ◽

Disease Modifying Therapy ◽

The Us ◽

Disease Modifying

Abstract In the United States alone, the prevalence of AD is expected to more than double from six million people in 2019 to nearly 14 million people in 2050. Meanwhile, the track record for developing treatments for AD has been marked by decades of failure. But recent progress in genetics, neuroscience and gene editing suggest that effective treatments could be on the horizon. The arrival of such treatments would have profound implications for the way we diagnose, triage, study, and allocate resources to Alzheimer’s patients. Because the disease is not rare and because it strikes late in life, the development of therapies that are expensive and efficacious but less than cures, will pose particular challenges to healthcare infrastructure. We have a window of time during which we can begin to anticipate just, equitable and salutary ways to accommodate a disease-modifying therapy Alzheimer’s disease. Here we consider the implications for caregivers, clinicians, researchers, and the US healthcare system of the availability of an expensive, presymptomatic treatment for a common late-onset neurodegenerative disease for which diagnosis can be difficult.

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Proteolytic processing of the amyloid-beta protein precursor of Alzheimer's disease

Essays in Biochemistry ◽

10.1042/bse0380037 ◽

2002 ◽

Vol 38 ◽

pp. 37-49 ◽

Cited By ~ 27

Author(s):

Janelle Nunan ◽

David H Small

Keyword(s):

Alzheimer’S Disease ◽

Alzheimer's Disease ◽

Amyloid Beta ◽

Alternative Pathway ◽

Protein A ◽

Proteolytic Processing ◽

Gamma Secretase ◽

Amyloid Beta Protein ◽

Protein Precursor ◽

Amyloid Beta Protein Precursor

The proteolytic processing of the amyloid-beta protein precursor plays a key role in the development of Alzheimer's disease. Cleavage of the amyloid-beta protein precursor may occur via two pathways, both of which involve the action of proteases called secretases. One pathway, involving beta- and gamma-secretase, liberates amyloid-beta protein, a protein associated with the neurodegeneration seen in Alzheimer's disease. The alternative pathway, involving alpha-secretase, precludes amyloid-beta protein formation. In this review, we describe the progress that has been made in identifying the secretases and their potential as therapeutic targets in the treatment or prevention of Alzheimer's disease.

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