Canada Approves Leqembi: First Drug Proven to Slow Alzheimer’s Progression

Health Canada has officially approved Leqembi (generic name: lecanemab), a breakthrough therapy shown to slow the progression of Alzheimer’s disease in its early stages.

Leqembi, developed by Biogen and Eisai, is the first treatment in Canada proven to modify the underlying course of Alzheimer’s, rather than only manage its symptoms.

“This is the first time we have a drug that can actually slow the disease process,” said the Alzheimer Society of Canada in a statement following the approval.

Who can receive it?

The treatment is approved for people with mild cognitive impairment or early-stage Alzheimer’s who have confirmed amyloid buildup in the brain.

Patients must undergo diagnostic imaging, such as PET scans or spinal fluid tests, before starting therapy.

Unlike the U.S. FDA’s broader approval, Health Canada’s authorization adds an extra safety layer excluding individuals who carry two copies of the APOE ε4 gene, known to increase the risk of brain swelling or bleeding during treatment. The agency also mandates genetic testing and MRI monitoring before and during therapy.

How it works

Leqembi is a monoclonal antibody that targets amyloid plaques, abnormal protein clusters that damage brain cells. In large clinical trials, the drug slowed cognitive and functional decline by about 27% over 18 months compared to placebo, offering patients more time to maintain independence and daily function.

While promising, Leqembi comes with risks. The most serious is amyloid-related imaging abnormality (ARIA) – a potential side effect involving brain swelling or microbleeding. Most cases are mild or asymptomatic, but rare severe reactions have been reported.

To manage this, Health Canada requires treatment only in specialized infusion centers with trained staff and access to MRI facilities. Patients will receive intravenous infusions every two weeks at a dose of 10 mg/kg, with regular safety checks.

Though authorized, Leqembi is not yet publicly covered under provincial health plans. Alzheimer advocates expect coverage to take one to two years, while private insurers may move sooner. The drug’s U.S. cost is approximately $26,500 (USD) per year, raising questions about affordability and equitable access.

Canada joins the United States and Japan in approving Leqembi, marking a new era in Alzheimer’s treatment worldwide.

For healthcare professionals, particularly nurses and allied care providers, this breakthrough emphasizes the importance of early diagnosis, patient education, and long-term monitoring.