Elaine Suh, Class of 2023
Alzheimer’s Disease is a neurodegenerative disorder that leads to a decline in memory, thinking, and social function. It is the sixth leading cause of death in the United States and is the most common form of dementia in older adults. The disease was first discovered in 1906 by Dr. Alois Alzheimer who studied the brain of a woman who had passed away from an unusual mental illness with symptoms of memory loss, confusion, and language issues. He found that she had amyloid plaques, which are misfolded proteins between nerve cells thought to initially develop in brain regions dealing with memory and cognitive function and neurofibrillary tangles, which are tangled brain fibers. Today, these amyloid plaques are considered one of the defining features of Alzheimer’s Disease, along with decreased neuron connections and shrunken brain tissue. While scientists are unsure of the causes of the disease, it likely results from a combination of environmental, genetic, and lifestyle factors (Alzheimer’s Disease . . . 2019).
While there is currently no cure for the disease or a treatment to slow down the process, Biogen Inc., a biotechnology company based in Cambridge, Massachusetts, has been working on a treatment drug called aducanumab. If approved for use by the Food and Drug Administration (FDA), the drug would be the first treatment to slow down clinical decline that results from the disease and also the first new Alzheimer’s treatment in almost 20 years (Lovelace 2020). Aducanumab showed promising results from its Phase 1b trial in March of 2015, leading to more trials, but 2017 and 2018 trial results showed nothing substantial. This led Biogen to announce they were halting Phase 3 trials in March of 2019, as trials had not met the pre-established criteria to continue clinical trials (Knopman et al. 2020). However, in September of 2019, Biogen announced that reanalysis of a larger dataset of aducanumab Phase 3 trials revealed that aducanumab did reduce clinical decline and damage to the brain (Biogen Plans . . . 2019). After filing the biologics license application (BLA) in July of 2020, the FDA accepted the application in August of 2020, and set aducanumab’s Prescription Drug User Fee Act (PDUFA) date, the date by which the FDA will decide whether to approve the drug, to March of 2021 (Vounatsos 2020).
The most recent update on aducanumab’s status came in November of 2020, where an FDA committee, which consisted of independent Alzheimer’s Disease statistics experts, reviewed three major studies presented by Biogen (Edney 2020). Mixed reviews of the data occurred within the FDA, as a report prepared by the FDA before the committee meeting supported aducanumab’s efficacy, stating results were persuasive (Lovelace 2020), while the independent statistician experts concluded in an 8 to 1 vote that the data was insufficient to show efficacy, since there was only one clinical trial with clear positive results. Despite this setback, the drug will still be reviewed and decided on by the FDA by March of 2021 (Edney 2020).
Aducanumab works by attacking the amyloid plaques and successfully removing them. Scientists are not sure of the role of these proteins in Alzheimer’s Disease, and it is uncertain if removal leads to benefits (Edney 2020).
Currently, treatment drugs to help people maintain and manage the symptoms of the disease are offered, although there are no treatments to stop the disease. In mild and moderate Alzheimer’s Disease, cholinesterase inhibitors are prescribed and help to prevent breakdown of acetylcholine, which appears to be an important chemical in cognitive function and memory. In moderate and severe Alzheimer’s Disease, the prescription treatments serve to decrease symptoms and allow for more independent function for a longer period (How is Alzheimer’s . . . 2018).
Many families with loved ones with Alzheimer’s Disease and scientists around the world are hopeful for aducanumab, as a new treatment would potentially help to slow the mental and physical decline associated with the disease and provide morale.
References:
Alzheimer's Disease Fact Sheet. National Institute on Aging. 2019 May 22 [accessed 2020 Dec 2]. https://www.nia.nih.gov/health/alzheimers-disease-fact-sheet
Bigica A. FDA Accepts Aducanumab for Review as Alzheimer Disease Treatment. Neurology live. 2020 Aug 7 [accessed 2020 Dec 2]. https://www.neurologylive.com/view/fda-accepts-aducanumab-for-review-as-alzheimer-disease-treatment
Biogen Plans Regulatory Filing for Aducanumab in Alzheimer's Disease Based on New Analysis of Larger Dataset from Phase 3 Studies. Biogen. 2019 Oct 22 [accessed 2020 Dec 2]. https://investors.biogen.com/news-releases/news-release-details/biogen-plans-regulatory-filing-aducanumab-alzheimers-disease
Edney A. Biogen Alzheimer’s Drug Fails to Gain FDA Panel’s Backing. Bloomberg. 2020 Nov 6 [accessed 2020 Dec 2]. https://www.bloomberg.com/news/articles/2020-11-06/biogen-alzheimer-s-drug-fails-to-gain-fda-panel-s-backing
How Is Alzheimer's Disease Treated? National Institute on Aging. 2018 Apr 1 [accessed 2020 Dec 2]. https://www.nia.nih.gov/health/how-alzheimers-disease-treated
Knopman DS, Greicius MD, Jones DT. Failure to demonstrate efficacy of aducanumab: An analysis of the EMERGE and ENGAGE trials as reported by Biogen, December 2019. Alzheimer's & Dementia: The Journal of the Alzheimer's Association. 2020 Nov 1 [accessed 2020 Dec 3]:1–6. doi:https://doi.org/10.1002/alz.12213
Lovelace Jr. B. Biogen hits snag after Alzheimer's drug fails to win support from FDA panel. CNBC. 2020 Nov 6 [accessed 2020 Dec 3]. https://www.cnbc.com/2020/11/06/biogen-suffers-setback-after-alzheimers-drug-fails-to-win-support-from-fda-panel-.html
Image: https://www.unibas.ch/en/News-Events/News/Uni-Research/Potential-indicator-for-the-early-detection-of-dementias.html
While there is currently no cure for the disease or a treatment to slow down the process, Biogen Inc., a biotechnology company based in Cambridge, Massachusetts, has been working on a treatment drug called aducanumab. If approved for use by the Food and Drug Administration (FDA), the drug would be the first treatment to slow down clinical decline that results from the disease and also the first new Alzheimer’s treatment in almost 20 years (Lovelace 2020). Aducanumab showed promising results from its Phase 1b trial in March of 2015, leading to more trials, but 2017 and 2018 trial results showed nothing substantial. This led Biogen to announce they were halting Phase 3 trials in March of 2019, as trials had not met the pre-established criteria to continue clinical trials (Knopman et al. 2020). However, in September of 2019, Biogen announced that reanalysis of a larger dataset of aducanumab Phase 3 trials revealed that aducanumab did reduce clinical decline and damage to the brain (Biogen Plans . . . 2019). After filing the biologics license application (BLA) in July of 2020, the FDA accepted the application in August of 2020, and set aducanumab’s Prescription Drug User Fee Act (PDUFA) date, the date by which the FDA will decide whether to approve the drug, to March of 2021 (Vounatsos 2020).
The most recent update on aducanumab’s status came in November of 2020, where an FDA committee, which consisted of independent Alzheimer’s Disease statistics experts, reviewed three major studies presented by Biogen (Edney 2020). Mixed reviews of the data occurred within the FDA, as a report prepared by the FDA before the committee meeting supported aducanumab’s efficacy, stating results were persuasive (Lovelace 2020), while the independent statistician experts concluded in an 8 to 1 vote that the data was insufficient to show efficacy, since there was only one clinical trial with clear positive results. Despite this setback, the drug will still be reviewed and decided on by the FDA by March of 2021 (Edney 2020).
Aducanumab works by attacking the amyloid plaques and successfully removing them. Scientists are not sure of the role of these proteins in Alzheimer’s Disease, and it is uncertain if removal leads to benefits (Edney 2020).
Currently, treatment drugs to help people maintain and manage the symptoms of the disease are offered, although there are no treatments to stop the disease. In mild and moderate Alzheimer’s Disease, cholinesterase inhibitors are prescribed and help to prevent breakdown of acetylcholine, which appears to be an important chemical in cognitive function and memory. In moderate and severe Alzheimer’s Disease, the prescription treatments serve to decrease symptoms and allow for more independent function for a longer period (How is Alzheimer’s . . . 2018).
Many families with loved ones with Alzheimer’s Disease and scientists around the world are hopeful for aducanumab, as a new treatment would potentially help to slow the mental and physical decline associated with the disease and provide morale.
References:
Alzheimer's Disease Fact Sheet. National Institute on Aging. 2019 May 22 [accessed 2020 Dec 2]. https://www.nia.nih.gov/health/alzheimers-disease-fact-sheet
Bigica A. FDA Accepts Aducanumab for Review as Alzheimer Disease Treatment. Neurology live. 2020 Aug 7 [accessed 2020 Dec 2]. https://www.neurologylive.com/view/fda-accepts-aducanumab-for-review-as-alzheimer-disease-treatment
Biogen Plans Regulatory Filing for Aducanumab in Alzheimer's Disease Based on New Analysis of Larger Dataset from Phase 3 Studies. Biogen. 2019 Oct 22 [accessed 2020 Dec 2]. https://investors.biogen.com/news-releases/news-release-details/biogen-plans-regulatory-filing-aducanumab-alzheimers-disease
Edney A. Biogen Alzheimer’s Drug Fails to Gain FDA Panel’s Backing. Bloomberg. 2020 Nov 6 [accessed 2020 Dec 2]. https://www.bloomberg.com/news/articles/2020-11-06/biogen-alzheimer-s-drug-fails-to-gain-fda-panel-s-backing
How Is Alzheimer's Disease Treated? National Institute on Aging. 2018 Apr 1 [accessed 2020 Dec 2]. https://www.nia.nih.gov/health/how-alzheimers-disease-treated
Knopman DS, Greicius MD, Jones DT. Failure to demonstrate efficacy of aducanumab: An analysis of the EMERGE and ENGAGE trials as reported by Biogen, December 2019. Alzheimer's & Dementia: The Journal of the Alzheimer's Association. 2020 Nov 1 [accessed 2020 Dec 3]:1–6. doi:https://doi.org/10.1002/alz.12213
Lovelace Jr. B. Biogen hits snag after Alzheimer's drug fails to win support from FDA panel. CNBC. 2020 Nov 6 [accessed 2020 Dec 3]. https://www.cnbc.com/2020/11/06/biogen-suffers-setback-after-alzheimers-drug-fails-to-win-support-from-fda-panel-.html
Image: https://www.unibas.ch/en/News-Events/News/Uni-Research/Potential-indicator-for-the-early-detection-of-dementias.html
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