For the first time, Health Canada has approved a new drug that can slow the progression of Alzheimer’s disease and it’s giving new hope that the disease can be tackled early.
On Monday, Health Canada announced approval for lecanemab, commercially known as “Leqembi.”
The treatment has already been approved in some other countries, including the U.S., the U.K., Japan, Mexico and China. It is currently under regulatory review in 15 other countries and regions, including the European Union.
Lecanemab is meant for adults who have a clinical diagnosis of mild dementia due to Alzheimer’s disease.
Lecanemab is the first new Alzheimer’s treatment approved by Health Canada in more than a decade and the first to target the underlying biology of the disease, the Alzheimer Society of Canada said.
“Clinical studies show that lecanemab can help slow decline in memory, thinking and daily activities for people with mild cognitive impairment or early-stage Alzheimer’s disease,” the society said in a statement, welcoming Health Canada’s approval.
“This is a big deal,” said Dr. Sharon Cohen, a neurologist and the medical director of Toronto Memory Program.
Lecanemab targets amyloids, a sticky protein that develops in the brain in the early stages of Alzheimer’s disease, Cohen said.
“We’ve only had treatments up until now that deal with symptoms later in the disease, not the early brain changes,” she added.
By clearing amyloids and treating the disease early, the drug could help keep symptoms mild for a longer period for many patients, Cohen said.
She said the treatment could do more than just “boost memory for a little while.” It could potentially slow the progression of the disease down.
“Most people at four years of treatment are staying mild, are staying in their own homes, independent, so (the number of people) progressing to the moderate or severe stage of disease is really in the minority,” she added.
Health Canada has limited use of the treatment for people who don’t carry the APOE4 gene.
This genetic variant, carried by one-fifth of the world’s population, significantly increases the risk of dementia.
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The agency has placed the limitation because of the higher risk of side effects for anyone who may have that gene.
“Research shows that this group faces a much higher risk of brain swelling and small brain bleeds when taking the medication,” the Alzheimer Society of Canada said.
Health Canada’s restriction is in line with international standards. The Alzheimer Society of Canada said Canadians should get tested for the gene to find out if they are eligible for treatment.
However, the group warned that access to testing may vary across provinces and territories. This means that depending on where they live, Canadians may face delays in getting the treatment.
In Canada, it can take up to two years after regulatory approval for new medicines to become publicly covered, the Alzheimer Society said.
However, people with private or extended benefits often gain access much sooner.
“The Alzheimer Society of Canada urges faster, more coordinated reimbursement processes so that approval translates into timely, equitable access for all Canadians,” the group said.
Another challenge to access is the fact that the drug is administered intravenously, which requires safety monitoring through regular MRIs. Those may be hard to access outside of Canada’s large urban centres.
Currently, the drug is not covered under any public drug plan.
It is now up to Canada’s Drug Agency (CDA-AMC) to decide if it should be paid for by the government. After that, each province and territory will decide on pricing and coverage.
In the United States, where the drug was approved by the Food and Drug Administration (FDA) in 2023, the list price is US$258.64 for a 200 mg vial and US$646.61 for a 500 mg vial as of April 2025.
Total annual costs for the treatment can run up to $26,000 US a year in other countries, The Canadian Press reported, noting the drug must be administered every two weeks.
While this new treatment is “helpful” in some ways, “this is certainly not going to be the silver bullet that is going to resolve the issues of dementia,” said Dr. Samir Sinha, Sinha, director of health policy research at the National Institute on Ageing.
“You have to be put on it at a very, very early stage of the illness,” he said.
This means frequent and routine MRIs are needed to check if a patient is having side effects such as microbleeds in the brain, he warned.
“We still don’t know whether being on it for 18 or more months and paying a lot of money and going through a lot of burden of being on it is going to generate any clinically significant benefits,” he said.
He said while the treatment has “some disease-modifying properties,” it is by no means a cure for dementia.
“It’s not a medication that I would recommend for most of the patients that I see with dementia, given the side effect profile, given the cost, the fact that it’s not covered, and the fact that I’m not still sure whether it’s going to generate a clinically significant or clinically meaningful benefit,” he said.
While experts warn against seeing this as a “cure,” Cohen said it is a major step forward in treating Alzheimer’s disease nonetheless.
There are other treatments that tackle the disease in its early stages that might be coming down the pipeline soon, she said.
“Donanemab is also an antibody that clears amyloid. It’s very specific to amyloid plaque and it is under review by Health Canada,” she said.
“We expect that it will gain Health Canada approval perhaps (by) the first quarter of 2026.”