Donanemab receives approval

On May 1, 2026, Health Canada announced their approval of donanemab for people with mild cognitive impairment or early-stage Alzheimer’s disease. This decision marks another significant advancement in the treatment of Alzheimer’s disease, as it is the second approved treatment in Canada designed to target the underlying biology of the disease.  

The announcement follows Health Canada’s recent conditional approval of lecanemab, the first new treatment for Alzheimer’s disease in more than a decade. Similar to lecanemab, donanemab is administered via intravenous infusions. It targets amyloid plaques that contribute to cognitive decline and allows a person’s immune system to clear them from the brain. Unlike lecanemab, however, people are able to stop taking donanemab once their amyloid levels drop below a certain threshold. 

Clinical studies show that donanemab can help slow decline in memory, thinking and daily activities for people with mild cognitive impairment or mild dementia due to Alzheimer’s disease. 

“This decision signals another exciting step forward and such meaningful progress in our approach to Alzheimer’s disease treatment and care,” said Dr. Heather Cooke, Manager of Research & Knowledge Mobilization for the Alzheimer Society of BC and Yukon. “We need more treatment options and we will continue to advocate for equitable access to them.” 

Health Canada has decided to limit donanemab access to people who have one or no copies of the APOE4 gene, which potentially increases the risk of developing Alzheimer’s disease at a younger age. While only a small percentage of people have two copies of the APOE4 gene, research shows that this group faces a much higher risk of brain swelling and small brain bleeds when taking the medication. This decision follows the same guidelines put in place for use of lecanemab and aligns with those in other countries. It also means more British Columbians and Yukoners will need genetic testing to find out if they’re eligible for treatment, as well as regular MRI scans to monitor for brain swelling or bleeds. In BC, additional testing is required to confirm the presence of amyloid plaque in the brain before treatment can begin. Access to necessary testing and monitoring varies across regions, which will affect who is able to receive the therapy safely and effectively.

While Health Canada has approved donanemab, it doesn’t mean it’s available to British Columbians and Yukoners just yet. Health Canada’s approval only means the drug can be marketed. The next step is for Canada’s Drug Agency to review the drug for cost-effectiveness and decide if it should be paid for by the government. After that, each province and territory will decide on pricing and coverage. Access through public drug plans typically takes at least two years from the date of the Health Canada announcement, while access through private drug plans typically occurs within a year. You can read more about  this process here. 

“Despite the barriers to access, this approval announcement marks a hopeful moment built on the momentum of other recent advancements in Alzheimer’s disease treatment,” Dr. Cooke says. “Our hope is that we’re now amid a new era of increasingly effective treatments that will be available to anyone in need.”