Home / Regulatory / Health Canada approves Kisunla (donanemab) by Lilly Canada for early Alzheimer’s disease 

Health Canada approves Kisunla (donanemab) by Lilly Canada for early Alzheimer’s disease 

  • Health Canada has approved Kisunla (donanemab) by Lilly Canada as a once-monthly treatment for adults with early symptomatic Alzheimer’s disease, including mild cognitive impairment and mild dementia with confirmed amyloid pathology 
  • In the Phase 3 TRAILBLAZER-ALZ 2 study, Kisunla slowed cognitive and functional decline by 35% in patients at the earliest disease stage and reduced progression to the next stage of disease by up to 40% 
  • The amyloid-targeting therapy is designed to clear plaque buildup in the brain, with some patients able to stop treatment after plaques were sufficiently cleared, as early as 6 months for some participants 
  • With >770K Canadians living with Alzheimer’s disease and prevalence expected to double by 2050, the approval marks a major milestone in disease-modifying Alzheimer’s treatment, while also highlighting the need for broader diagnostic access and healthcare system readiness 

Takeaways: 

Kisunla adds a new money‑maker for Lilly in Canada, but real sales will depend on how fast the system can diagnose patients early and pay for the drug. 

Because testing and specialist visits are limited, most use will likely start in big cities and grow slowly, even though the number of people with Alzheimer’s is rising quickly. 

Source: CA Newswire 

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