The United States Food and Drug Administration (FDA) has approved the first new drug developed for Alzheimer’s disease in more than 20 years – but the decision and the drug itself appear to be controversial.
The drug, known as Aduhelm (scientific name: aducanumab) has been developed by the Cambridge, Massachusetts-based company Biogen together with Japanese company Eisai Co. Its approval appears to hinge on the fact that US regulators believe it is the only one that could treat the underlying disease, rather than manage symptoms.
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The purpose of the drug is to clear harmful accumulations of a protein called beta-amyloid from the brain. This naturally occurring protein appears to be abnormally high in the brains of Alzheimer’s patients, causing it to clump together to form plaques that collect between neurons and disrupt cell function, which in turn leads to cell death.
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Initially, Alzheimer’s disease tends to destroy neurons and their connections in parts of the brain used for memory. It later affects areas in the cerebral cortex responsible for language, reasoning, and social behaviour. In the long term, many other areas of the brain are damaged, leading to the patient losing their ability to function independently.
There is controversy over Aduhelm, however, because independent advisors to the FDA have warned that the treatment has not conclusively been shown to slow the progression of dementia. The drug does not reverse the mental decline, and only one study seems to have indicated that it may slow it.
The FDA is requiring that the drug-maker conduct further studies to confirm the benefit of the drug for patients. If it fails to prove effective, it could be pulled from the market.
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Why approve a drug if there is still much controversy surrounding it? The FDA believes that the potential benefits outweigh the risks because there is such a great unmet need for effective Alzheimer’s treatments.
According to Alzheimer’s News Today, there are an estimated 44-million people worldwide living with Alzheimer’s disease or a related form of dementia. There is currently no effective cure or treatment for Alzheimer’s disease, so one can understand the reason for the controversy.
On the one hand, approving a drug that has not yet proven its benefits conclusively could set a dangerous precedent. On the other hand, groups representing Alzheimer’s patients and their families say that any new therapy, even if it has a small benefit, warrants approval.
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“Specialised care is required for people living with dementia,” said Barry Kaganson, CEO of Auria Senior Living. “We believe the best environment is a residential setting which is properly tailored to their needs. Such an environment provides staff who are trained to deal with their particular requirements and offers appropriate and meaningful activities and wellness programmes.
“Many dementia sufferers can still live a life of interest and meaning – often without excessive medication. A caring and compassionate environment where help is provided with aspects of daily living such as routine, exercise, balanced diet and healthy activity can still give a person quality of life despite their condition,” said Kaganson.
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