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Health Canada Conditionally Authorizes First Alzheimer’s Drug to Slow Early Decline

Access remains uncertain—strict eligibility rules, scarce testing capacity, pending funding decisions.

Overview

  • Lecanemab (Leqembi) received conditional authorization for people with mild cognitive impairment or early Alzheimer’s, marking Canada’s first disease‑modifying therapy for the disease.
  • Health Canada advises against use in patients with two copies of the APOE e4 gene because of higher risks of brain swelling and microbleeds.
  • The therapy is given by IV every two weeks and requires amyloid confirmation plus MRI monitoring, including a baseline scan and four MRIs in the first year.
  • Eisai has not set a Canadian price; the U.S. list price is about US$26,500 per year, and advocates are pressing for timely public coverage to avoid inequitable access.
  • Eligibility steps such as APOE testing and amyloid PET or lumbar puncture, coupled with limited MRI and infusion capacity, are expected to constrain rollout despite approvals in roughly 50 countries.