Canada Approves Groundbreaking Alzheimer’s Drug, Lecanemab

Canada has made a significant advancement in the fight against Alzheimer’s disease with the approval of a new drug, lecanemab, by Health Canada. Announced on March 15, 2024, this medication is the first in Canada to target the underlying causes of Alzheimer’s, aiming to slow cognitive and functional decline rather than solely manage symptoms. Dr. Sharon Cohen, a neurologist and medical director at the Toronto Memory Program, highlighted the drug’s potential to change the trajectory of the disease for many Canadians.

Lecanemab, developed by Japanese pharmaceutical company Eisai Ltd. and U.S. biotechnology firm Biogen Inc., received conditional authorization after extensive clinical trials. It is designed for patients experiencing mild cognitive impairment or mild dementia due to Alzheimer’s. The drug works by clearing beta-amyloid proteins from the brain, which are known to contribute to the death of brain cells and are a hallmark of Alzheimer’s.

Dr. Cohen noted, “This is an important milestone. What this does is slow down the disease at an early stage where people are still living at home and functioning quite well.” According to her estimates, Canadian patients may begin receiving their first doses of lecanemab by the end of 2025. In the United States, where the drug has already been approved, it carries a price tag of approximately 26,500 USD annually.

Long Journey to Approval

The approval process for lecanemab in Canada took more than two years, exceeding the typical review timeframe by Health Canada. Despite this delay, the drug has already been approved in over 51 countries, including the U.S., Japan, and members of the European Union. Dr. Cohen pointed out that around 35,000 individuals are currently being treated with lecanemab, providing a substantial amount of real-world evidence supporting its efficacy.

While lecanemab does not cure Alzheimer’s, it can slow its progression by an estimated 10 to 13 months, offering patients and their families valuable additional time to engage in meaningful activities and maintain independence. Dr. Cohen emphasized that many Alzheimer’s patients worry about losing their ability to make decisions and manage their lives. She stated, “If you catch it early and slow it down, people can have a lot more time to do the things that matter to them.”

According to the Alzheimer Society of Canada, approximately 771,000 Canadians currently live with dementia. This number is projected to rise to one million by 2030 and over 1.7 million by 2050, highlighting the urgent need for effective treatments.

Challenges Ahead

Despite the promising nature of lecanemab, some experts urge caution. Dr. Stephen Pasternak, a cognitive neurologist and associate professor at Western University, described it as “a major technical advance,” but noted it does not halt the disease entirely. “It is not the slam dunk that we hoped for,” he said. “It does not stop people from getting worse, but the disease is slowed. It appears to only be helpful in the mildest patients.”

The exact cost of lecanemab in Canada is yet to be disclosed, but it is anticipated to be significant. Dr. Pasternak raised concerns about access to neurologists and geriatricians who will be responsible for diagnosing and managing treatment. He noted that patients may face long waiting times, potentially missing the eligibility window for treatment.

The administration of lecanemab requires patients to receive an intravenous infusion every two weeks. Prior to starting treatment, patients must undergo an MRI, as well as several follow-up MRIs during the first year to monitor for serious side effects, which occur in less than one percent of cases. The availability of MRI services may pose an additional barrier to treatment, especially in regions with limited access.

Dr. Cohen expressed optimism that, despite these challenges, the medical community will adapt to the new treatment landscape. She acknowledged that while some geographical areas may struggle with MRI access, the overall response from radiologists has been positive.

Health Canada has indicated that lecanemab should not be administered to individuals carrying two copies of the APOE e4 gene, a known genetic risk factor for Alzheimer’s. Additionally, prospective patients must be tested for beta-amyloid protein presence to qualify for treatment.

As Canada joins other countries in offering lecanemab, experts like Dr. Paolo Vitali from McGill University emphasize the drug’s significance. He stated that this approval represents a “clinically meaningful benefit for our patients” and marks the first effective pharmacological treatment for Alzheimer’s in Canada in over 25 years.

The introduction of lecanemab reflects growing recognition of the need to invest in Alzheimer’s treatments that can improve the quality of life for patients and alleviate the burden on families and healthcare systems. As the population ages, embracing innovative solutions like lecanemab could prove essential in managing the impending increase in dementia cases across Canada.