Health Canada approves drug that slows progression of Alzheimer’s disease

Health Canada has for the first time approved a disease-modifying drug for Alzheimer’s disease, a watershed moment that offers hope for patients but does not guarantee that the complex and expensive intravenous therapy will be widely available in this country.

The federal regulator on Friday granted a conditional authorization for lecanemab, an antibody drug that can slow the progression of the disease for some people with mild cognitive impairment or early-stage dementia owing to Alzheimer’s.

Health Canada approved the drug two-and-a-half years after Japan’s Eisai Ltd. applied to sell it in Canada, an unusually long review time for a regulator that aims to make decisions in 300 calendar days.

“I’m overjoyed. It’s about time,” said Sharon Cohen, medical director of the Toronto Memory Program and one of the researchers who worked on the lecanemab clinical trials. “To keep people mild longer, living in their own homes, doing the things that are meaningful to them – this is huge.”

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Lecanemab’s approval is significant because it marks the first time Canada has greenlit a drug designed to affect the root cause of Alzheimer’s disease. The existing drugs only mitigate symptoms, and most were approved more than 20 years ago.

However, lecanemab doesn’t stop the relentless march of Alzheimer’s disease, it just slows it down. The medication, sold under the brand name Leqembi, also comes with a hefty price tag and a risk of rare but severe side effects, including microbleeds and swelling in the brain.

About 50 other countries have already approved it, according to Patrick Forsythe, the vice-president and general manager in Canada for Eisai, which co-developed the drug with Biogen Inc.

“It’s been a long time coming,” Mr. Forsythe said.

The United States Food and Drug Administration approved lecanemab in 2023. Japan followed the same year, while China approved in 2024. The European Commission granted marketing authorization in April, albeit with a stricter set of criteria for who should take the drug than in the United States.

The Alzheimer Society of Canada estimates that more than 770,000 Canadians are living with dementia, an umbrella term for reduced memory and thinking skills. Alzheimer’s disease is its most frequent cause.

Lecanemab, which is taken every two weeks by IV, targets and clears beta-amyloid a protein that congeals into sticky clumps in the brain, triggering a cascade of events that lead to brain cell death.

There is a continuing scientific debate about whether beta-amyloid buildup causes Alzheimer’s, but the plaques are a telltale biological feature that separates the disease from other causes of dementia.

One concern with lecanemab is the risk it presents for microbleeds and swelling in the brain. The likelihood of suffering those side effects is higher if patients have two copies of the APOE e4 gene, a variation that also raises the risk of late-onset Alzheimer’s.

For that reason, Health Canada indicated that lecanemab should not be given to people with two copies of APOE e4, Mr. Forsythe said. European regulators and their counterparts in several other countries imposed the same criteria, Mr. Forsythe added. The United States did not.

Another issue with lecanemab is its cost, both in terms of the drug’s price, and the requirement that patients receive frequent MRIs in the first year of treatment.

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Mr. Forsythe said Eisai had not yet decided on a price for lecanemab in Canada. The sticker price of the treatment in the U.S. is US$26,500 a year. Patients need one MRI before starting the drug, and four MRIs in the first year to monitor for side effects.

Some patients are also ready and willing to pay out of pocket, Mr. Forsythe added. He’s aware of Canadians who are crossing the border to Buffalo and Seattle to receive the treatment.

Dr. Cohen said her Toronto clinic is ready to begin offering the drug as soon as supply is available. The Toronto Memory Program gets funding from pharmaceutical companies, including Eisai, but Dr. Cohen does not receive any money from the drug maker personally.

Adam Morrison, senior director of public policy and partnerships at the Alzheimer Society of Ontario, said the approval of a disease-modifying drug for early Alzheimer’s “means hope” for the people his organization serves.

His hope now is that lecanemab won’t be limited to Canadians with robust private insurance or deep pockets.

“We really don’t want there to be a barrier in terms of ability to pay,” Mr. Morrison said.

The Alzheimer Society of Ontario also receives funding from the pharmaceutical industry, including from Eisai.