An Alzheimer’s drug that can stop the progression of the disease is called a “game changer”.
The addiction-robbing disorder has no cure, with existing treatments working to reduce its symptoms.
In severe cases, patients may become aggressive, struggle to move or even hallucinate.
Hopes have been raised after the US Food and Drug Administration (FDA) granted the drug aducanumab fast-track approval.
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Trials have shown that aducanumab helps in the untangle of Alzheimer’s-tell protein clots in the brain, potentially reversing the disease.
The FDA has not considered a new treatment for the condition in 17 years, with the fate of aducanumab by March 7, 2021.
If licensed, it would be the first therapy approved to slow the progression of Alzheimer’s.
‘A new era for Alzheimer’s treatments’
“The FDA’s approval of aducanumab with priority review is an important step on the path to potentially a treatment that alters the course of Alzheimer’s disease signal,” said Michel Vounatsos, CEO of manufacturer Biogen , as reported by Global News Wire.
“We believe aducanumab marks the beginning of a new era of potential treatments for Alzheimer’s disease, which will inspire even more discovery and innovation to bring hope to those affected by this devastating disease.”
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More than 5 million people in the US have Alzheimer’s, which is expected to increase to more than 13 million by 2050.
In the UK, about 850,000 people have dementia – the umbrella term for conditions that cause a slow decline in brain function.
Alzheimer’s is the most common type of dementia, affecting between 50% and 75% of patients in the UK.
The disease is thought to be caused by the abnormal buildup of proteins in and around brain cells.
Two of these are amyloid – which forms plaques, and tau – which develops into tangles.
Over time, the chemical messages that send signals between brain cells decay.
Different areas of the vital organ shrink then, usually starting with those responsible for memories.
Trials have shown that aducanumab works untangle these clots, and slows memory loss.
The medicine was also linked to improvement in a patient’s ability to perform daily tasks, such as household chores and leaving home alone.
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“I hear what progress can mean for people living with Alzheimer’s disease and their families,” said Dr. Christopher van Dyck, of the Yale Alzheimer’s Disease Research Center.
“If aducanumab is determined to be effective in reducing the decline in cognition and activities of daily living that results in the progression of this disease by addressing the underlying disease pathology, it will provide significant benefits to those who they need it most. “
Keeps patients ‘in a better place for longer’
Aducanumab has had a bumpy road. Studies were discontinued in March 2019 after two late-stage tests suggested it was of no benefit.
Several months later, Biogen looked at a larger amount of data available after the trials stopped.
It found that the drugs were effective, provided they were given early enough and at an adequate dose.
Experts hope that aducanumab will benefit those with early signs of dementia, and will help stop or slow the disease before patients become unfit.
The FDA has set an “action day” of March 7, 2021, but “intends to act early on this application under rapid review”.
Michael Yee, an analyst at investment bank Jefferies, expects a verdict in the first quarter of 2021, adding the data proving that the drug’s effectiveness is “mixed and still inconclusive,” Fierce Biotech reported.
However, the fast-track approval suggests that the FDA is “comfortable with all the data, recognizes high unnecessary need and really wants to get an Alzheimer’s drug approved,” he added.
Analyst Brian Abrahams, of RBC Capital Markets, has given aducanumab a 30% chance of approval.
Dr Dennis Selkoe from Harvard told wbur: “I think there’s a good chance that aducanumab, if approved and we do not yet know it, is the first disease-causing agent for Alzheimer’s, and that will be a huge milestone, and patients of me and others can access the drug.
‘If you had cared for hundreds of patients with this disease, this would be a game-changer.
“At least for some of my patients, if aducanumab is approved, [it would be] something that will slow down her decline, that will keep her in a better place for a longer period of time. “
The FDA only approves medicines for priority review if they offer significant advances in treatments or provide a therapy where none existed.
If approved in the US, experts are confident that other health watch dogs around the world will consider doing the same.
In the meantime, Biogen plans further studies, which will offer high doses to all eligible participants from the previous trials.
