LILLY CANADA WELCOMES POSITIVE CDA-AMC RECOMMENDATION TO REIMBURSE KISUNLA® (DONANEMAB) FOR EARLY ALZHEIMER'S DISEASE

Canada is among the first internationally recognized HTA bodies to issue a positive reimbursement recommendation for donanemab*

TORONTO, Nov. 6, 2026 /CNW/ -- Eli Lilly Canada Inc. is pleased to announce that Canada's Drug Agency (CDA-AMC) has issued a positive recommendation to reimburse Kisunla® (donanemab), a treatment received once every four weeks, for eligible adults diagnosed with early symptomatic Alzheimer's disease.¹  Canada is among the first internationally recognized health technology assessment (HTA) bodies to issue a positive reimbursement recommendation for donanemab.*

"We applaud the positive recommendation from Canada's Drug Agency (CDA-AMC) for Kisunla, which recognizes the importance of giving eligible patients with early symptomatic Alzheimer's disease a treatment option at a time when intervention matters," said Mathilde Merlet, President and General Manager, Lilly Canada. "Lilly remains committed to working with governments and the broader healthcare ecosystem to accelerate access to Kisunla. Our pursuit of meaningful advances for people living with early symptomatic Alzheimer's disease is relentless, and we will make every effort so that eligible patients in Canada can get the care they deserve."

Alzheimer's disease is a type of dementia that affects memory, thinking and behaviour.² Alzheimer's accounts for 60-80% of all dementia diagnoses.³ More than 770,000 people in Canada were estimated to be living with dementia including Alzheimer's in 2025, and that number is projected to increase to 1.7 million by 2050.⁴

Alzheimer's disease is also a leading cause of death and disability and carries an estimated economic impact of $40 billion annually.⁵ Against this backdrop, access to disease-modifying treatments may offer eligible people living with Alzheimer's disease and their care partners a new option, supporting efforts to preserve independence and quality of life for as long as possible.

"Treatments that can slow progression of Alzheimer's disease are incredibly meaningful as they preserve time and independence," said Christina Scicluna, CEO, Alzheimer Society of Canada. "Today's recommendation brings new treatment options one step closer to Canadians, creating hope for those who are affected by Alzheimer's disease while also underscoring the importance of all Canadians having access to a timely diagnosis."

Dr. Alexandre Henri-Bhargava, a behavioural neurologist and clinical researcher specializing in Alzheimer's and related conditions comments, "Kisunla represents an important step in changing the way we treat dementia. It is now the second treatment approved and recommended in Canada that can slow down Alzheimer's disease. Although the administration of drugs like Kisunla is complex, and only a minority of patients with a diagnosis of Alzheimer's disease are eligible, these drugs offer hope and meaningful slowing down of the disease for the first time. There will be others to come that will serve an increasing number of patients and it is important that our healthcare system adapts so that treatments like Kisunla can be offered to eligible patients. I hope that the provinces will heed the recommendation of the CDA so that eligible patients can have their treatments covered, which in turn will provide greater incentive for healthcare organizations to provide organized systems of care for families with Alzheimer's and related disorders. It is time for these conditions to receive the same priority from our healthcare system as other serious conditions like cancer and heart disease."

"The Fédération québécoise des Sociétés Alzheimer welcomes this recommendation, which represents an important step forward in access to new therapeutic options for people living with early-stage Alzheimer's disease. It is essential that these scientific advances translate into equitable, safe access, accompanied by appropriate clinical follow-up, for eligible individuals. This development also underscores the importance of continuing to invest in research, early diagnosis, and support for those affected and their loved ones," says Sylvie Grenier, Executive Director, Fédération québécoise des Sociétés Alzheimer.

Based on the submitted efficacy evidence, the Canadian Drug Expert Committee (CDEC), a committee of CDA-AMC, concluded that donanemab is a disease-modifying therapy that addresses an unmet clinical need for in patients with early Alzheimer's disease by reducing cognitive and functional decline. Input was also accepted from Canada's patient and healthcare professional communities.⁶ 

About Kisunla

Kisunla (donanemab for injection) (pronounced kih-SUHN-lah) is an amyloid-targeting therapy indicated for people with a clinical diagnosis of mild cognitive impairment (MCI) or mild dementia stage of early symptomatic Alzheimer's disease, who are apolipoprotein E ε4 heterozygotes or non-carriers, with confirmed amyloid pathology. The delay in clinical progression of cognitive impairment associated with donanemab treatment is believed to work by targeting amyloid plaques in the brain -- one of the key hallmarks of Alzheimer's disease. Kisunla can cause serious side effects, including amyloid-related imaging abnormalities, or ARIA, and infusion-related reactions.¹

Kisunla received authorization from Health Canada on April 30, 2026. ¹ In addition to Canada, Kisunla is approved in 48 markets, globally.

About Lilly Canada

Lilly is a medicine company turning science into healing to make life better for people around the world. Lilly has been pioneering life-changing discoveries for nearly 150 years, and today our medicines help more than 51 million people across the globe. Lilly's Canadian Affiliate, Eli Lilly Canada Inc. was established in 1938, the result of a research collaboration with scientists at the University of Toronto which eventually produced the world's first commercially available insulin.

Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world's most significant health challenges: redefining diabetes care; treating obesity and curtailing its most devastating long-term effects; advancing the fight against Alzheimer's disease; providing solutions to some of the most debilitating immune system disorders; and transforming the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we're motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable.

To learn more about Lilly Canada, visit www.lilly.com/en-CA, or follow us on LinkedIn and Instagram.

*  International HTA bodies most frequently referenced in Alzheimer's disease include NICE (UK), PBAC (Australia), TLV (Sweden), and AIFA (Italy), France (TC).

References:

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¹ Kisunla Product Monograph. May 14, 2026. Available at https://pi.lilly.com/ca/kisunla-ca-pm.pdf

² Alzheimer's Association. What is Alzheimer's? Available at https://www.alz.org/alzheimers-dementia/what-is-alzheimers Accessed September 2026.

³ Alzheimer Society. The difference between Alzheimer's disease and other dementias. Available at https://alzheimer.ca/en/about-dementia/what-alzheimers-disease/difference-between-alzheimers-disease-other-dementias Accessed September 2026.

⁴ Alzheimer Society. Dementia numbers in Canada. Available at https://alzheimer.ca/en/about-dementia/what-dementia/dementia-numbers-canada Accessed September 2026.

⁵ Canadian Centre for Economic Analysis. Dementia in Cannada: Economic Burden 202 to 2050. Available at https://www.cancea.ca/wp-content/uploads/2023/07/CANCEA-Economic-Impact-of-Dementia-in-Canada-2023-01-08.pdf Accessed September 2026.

⁶ Canada's Drug Agency. CDA-AMC Reimbursement Review. Patient and Clinical group Input. Donanemab. Available at SR0857_Patient_and_Clinician_Group_Input.pdf Accessed September 2026.

SOURCE Eli Lilly Canada Inc.

Media Contact: Ethan Pigott, Eli Lilly Canada Inc., [email protected], 416-770-5843