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Controversial Alzheimer’s drug approved in U.S. Where does Canada stand?

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There is fresh hope in the fight against the Alzheimer’s disease following the approval of a new drug in the United States.

Amid questions about its effectiveness and insufficient data, the U.S. Food and Drug Administration gave accelerated authorization to aducanumab –  the first new treatment approved for Alzheimer’s in nearly 20 years.

The development has drawn a mixed response among the scientific community.

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The Alzheimer Society of Canada welcomed the new treatment urging Canadian health authorities to complete its required reviews swiftly, so that the drug can be made available as quickly as possible to people living with dementia in the country.

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Dr. Saskia Sivananthan, chief science officer with the Alzheimer Society of Canada, said it was “entirely unacceptable” that there had been no treatments for dementia, which is the decline in mental ability most commonly caused by Alzheimer’s disease. But she was hopeful after the U.S. approval.

“This represents a breakthrough treatment that Alzheimer’s has not experienced for almost 20 years,” Sivananthan told Global News in an interview.

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While an important step in the fight against Alzheimer’s, aducanumab as a new treatment is “not a home run” said Dr. Howard Chertkow, scientific director at the Canadian Consortium on Neurodegeneration in Aging.

“We’re really a little unsure about how good this drug is going to be when it’s out in the market,” he told Global News.  

For the drug to be available and used in Canada, it will require regulatory approval by Health Canada to ensure its safety and efficacy.

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Drug manufacturers Biogen and Japan’s Eisai Co., told Global News that an application for aducanumab was submitted and accepted for review by Health Canada earlier this month.

The agency confirmed to Global News on Friday that they had received Biogen Canada’s submission on June 2.

Dementia and Alzheimer’s mostly affects older adults.

Nearly half a million Canadians over the age of 65 – two-thirds of them women – are currently living with dementia, according to the Public Health Agency of Canada (PHAC). That number is expected to double in 10 years, according to Sivananthan.

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So far, four medications have been approved for use and are available in Canada to treat Alzheimer’s disease: donepezil, rivastigmine, galantamine and memantine.

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There is no cure for Alzheimer’s. While the current medications help with symptom management, none of them can treat the underlying cause of the disease, said Sivananthan.

“Some of the issue with the current treatments available is that they don’t work very well for everyone … and there’s no effective therapy for Alzheimer’s disease at all right now,” she added.

How does aducanumab work?

Aducanumab, which will be marketed under the brand name Aduhelm, is given by intravenous infusion once a month.

The drug clears a protein called beta-amyloid that builds up in the brains of people with Alzheimer’s disease and is thought to trigger neurodegenerative processes that lead to the loss of memory and cognitive ability.

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Sivananthan said aducanumab may slow the decline in cognitive skills and functional ability, but it is focused only on those who are at the earlier stages of Alzheimer’s disease and who have been diagnosed with mild cognitive impairment.

If the beta-amyloid is in fact causing dementia or part of the dementia, then the drug will be helpful, but more research is needed, said Chertkow.

“We’ve learned that there are many older people who have amyloid in their brain and they live quite comfortably with it without ever having memory loss, so that certainly raises questions.”

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Under the terms of the so-called accelerated approval, the FDA is requiring the drugmaker to conduct a follow-up study to confirm benefits for patients.

According to the clinical trials, the most common side effects were temporary swelling in areas of the brain, headache, falls, diarrhea, and confusion, delirium or disorientation.

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If approved in Canada, price is going to be an issue, said Chertkow, who is also the chair in cognitive neurology and innovation at Baycrest’s Rotman Research Institute in Toronto.

Biogen did not immediately disclose the price, though analysts have estimated the drug could cost between $36,000 and $60,000 for a year’s worth of treatment.

A preliminary analysis by one group found that the drug would need to be priced between $3,000 to $10,000 per year to be a good value based on the “small overall health gains” suggested by company studies.

“This is not an inexpensive drug,” said Chertkow, adding that it could be “a burden” if it was released in Canada.

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In 2019, Canada launched its first national strategy on dementia to advance therapies and improve the quality of life for people living with dementia as well as their caregivers

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In January 2021, six new initiatives representing an investment of more than $4.8 million over four years were announced by the health ministry to help implement that strategy.

Going forward, greater funding for research will be needed to develop more therapeutics and treatments for people living with dementia and Alzheimer’s disease, both Chertkow and Sivananthan said.

— With files from The Associated Press

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