Company Announcements

Kisunla™ (donanemab) is the first and only amyloid plaque-targeting therapy with evidence supporting stopping treatment once amyloid plaques are cleared.

TORONTO , May 4, 2026 /CNW/ - Today, after more than 35 years of commitment to advancing Alzheimer's research, Lilly Canada announced Health Canada's approval of Kisunla™ (donanemab). Kisunla is approved as a once-monthly treatment for people living with early symptomatic Alzheimer's disease. Kisunla is indicated for the treatment of adults with a clinical diagnosis of mild cognitive impairment (MCI) or mild dementia due to Alzheimer's disease, who are apolipoprotein E ε4 (ApoE ε4) heterozygotes or non-carriers, and have confirmed amyloid pathology. In addition to Canada, Kisunla is approved in 48 markets, globally.

Alzheimer's disease is a rapidly growing public health issue--and as Canada faces rising rates of early Alzheimer's diagnoses, the societal impact is increasing. More than 770,000 Canadians are currently living with the disease, and prevalence is projected to double by 2050. Alzheimer's is also a leading cause of death and disability, with an economic toll estimated at $40 billion annually.¹⁷ Against this backdrop, the arrival of the first disease-modifying treatments is an important step toward giving people more time, quality of life, and independence.

"Alzheimer's disease is a devastating disease for people living with it--as well as for the families and friends who support them. With Health Canada's approval of Kisunla, Canadians with early symptomatic Alzheimer's disease now have a new treatment option proven to slow disease progression. Kisunla also showed evidence that treatment may be stopped once amyloid plaques are cleared," says Mathilde Merlet, President and General Manager, Lilly Canada. "But this is only the beginning. We will work with health systems and governments to help ensure Canadians can access this advanced treatment and we will keep tenaciously advancing the science behind Alzheimer's disease."

Kisunla targets amyloid plaques in the brain--one of the key features of Alzheimer's disease. In clinical trials, patients taking Kisunla were able to stop treatment once amyloid plaques were cleared, with some stopping as early as six months and nearly half discontinuing treatment after 12 months.

Amyloid is a protein produced naturally in the body that can clump together to create amyloid plaques. The excessive buildup of amyloid plaques in the brain may lead to memory and thinking issues associated with Alzheimer's disease. Kisunla helps the body remove the excessive buildup of amyloid plaques and slow the decline that may diminish people's ability to remember new information, important dates, and appointments; plan and organize; make meals; use household appliances; manage finances; and be left alone. In the indicated population, treatment with Kisunla reduced the risk of progressing to the next stage of disease by 40 per cent.^{1, 7-9} This means patients may remain in the earlier stages of the disease, with a higher level of functioning, for longer.

In the Phase 3 TRAILBLAZER-ALZ 2 study, patients in the earliest stages of disease, including those with mild cognitive impairment (MCI), experienced the greatest benefit. Over 18 months, participants who were less advanced in their disease showed a 35 per cent slowing of decline on the integrated Alzheimer's Disease Rating Scale (iADRS), which assesses memory, thinking and daily functioning, while the overall population showed a 22 per cent slowing. Across groups, treatment with Kisunla also reduced the risk of progression to the next clinical stage of disease by up to 39 per cent compared to placebo. ^{1, 10,11,12,13} 

One of the treatment goals of the study was to remove amyloid plaques to minimal levels consistent with a visually negative scan using amyloid positron emission tomography (PET). If participants were confirmed to have reached these levels, they were able to complete treatment with Kisunla and switch to placebo for the remainder of the study. Additionally, over three years of follow-up, the clinical benefit of Kisunla continued to widen versus the untreated natural history comparison arm, with no new safety concerns.¹⁸

Kisunla is not indicated for apolipoprotein E ε4 (ApoE ε4) homozygote carriers, as this population has a greater risk of amyloid-related imaging abnormalities (ARIA). Kisunla can cause ARIA, which is a potential side effect with amyloid plaque-targeting therapies that does not usually cause symptoms. It can be detected via magnetic resonance imaging (MRI) scans and, when it does occur, may present as temporary swelling in an area or areas of the brain. This usually resolves over time. ARIA can also present as small spots of bleeding in or on the surface of the brain. Infrequently, larger areas of bleeding in the brain can occur.^1, 2 ARIA can be serious, and life-threatening events can occur.

The Community Reacts:

"Changing the downward trajectory of Alzheimer's disease is of the utmost importance. Individuals at early stages of this disease live in their own homes and lead robust lives but often dread what is to come. Kisunla provides an important opportunity for early patients to maintain their independence, continue to engage in activities that they value, and to have a greater sense of hopefulness about their future." Dr. Sharon, Cohen, neurologist and medical director, Toronto Memory Program community-based medical facility.

"Today's authorization of Kisunla (donanemab) is a hopeful milestone for people living with early Alzheimer's and their care partners. While not a cure, it shows how far we've come and why research and advocacy matters. Together with our partners across Canada, we remain focused on ensuring people can access new treatments alongside the practical supports they need to navigate what comes next." Christina Scicluna, CEO, Alzheimer Society of Canada

"The Alzheimer Society of Ontario welcomes the approval of donanemab by Health Canada to be prescribed for eligible people living with mild cognitive impairment and Alzheimer's disease. We know from our clients that treatments for dementia like donanemab provide hope for more time with loved ones and extended independence. Approval of this drug creates more patient choice in the early stages of the dementia journey and marks an important step forward towards better care for people living with dementia and their care partners across the country." Cathy Barrick, CEO, Alzheimer Society of Ontario

"The approval of Kisunla marks a pivotal moment for people living with early-stage Alzheimer's disease in Canada, introducing a meaningful new tool to help modify the course of the disease," says Dr. Robert Laforce, Professor of Neurology, Faculty of Medicine, Laval University. "For individuals and families facing an Alzheimer's diagnosis, particularly in the early stages, this approval represents renewed hope and the possibility of intervening at a time when treatment can have the greatest impact. By offering the opportunity to slow disease progression when intervention matters most, Kisunla reinforces the importance of early diagnosis and timely access to care. At the same time, it underscores the urgent need for governments and health systems to work together to ensure equitable, timely access for patients across Canada, so that innovation can translate into real-world benefits for those who need it most."

"This is very good news and brings genuine hope for people affected by Alzheimer's disease and their loved ones. It confirms that research is moving toward treatments that target the biological mechanisms of the disease, rather than only its symptoms. For us, it remains essential that these innovations be integrated into a responsible, equitable, and well–understood approach, so that informed choices can be made." Sylvie Grenier, Executive Director, Fédération québécoise des Sociétés Alzheimer

"The approval of donanemab as a new therapeutic option represents an additional development and a step forward for people living with early-stage Alzheimer's disease and for the loved ones who support them. Decisions regarding treatment options are highly personal and should be discussed between individuals, their families, and healthcare professionals. Therapeutic approaches intended to slow disease progression may offer some people additional time for connection, independence, and planning. When considered alongside non-pharmacological supports, such approaches may contribute to quality of life and support individuals and families as they navigate the impact of the disease." Jeanne Day, Executive Director, Alzheimer's Montreal 

About TRAILBLAZER-ALZ 2 Study and the TRAILBLAZER-ALZ program
TRAILBLAZER-ALZ 2 (NCT04437511) is a Phase 3, double-blind, placebo-controlled study to evaluate the safety and efficacy of donanemab in participants with early symptomatic Alzheimer's disease (MCI or mild dementia due to Alzheimer's disease) with the presence of confirmed Alzheimer's disease neuropathology. The trial enrolled 1,736 participants, across 8 countries, selected based on cognitive assessments in conjunction with evidence of Alzheimer's disease pathology. The Phase 3 TRAILBLAZER-ALZ 2 study results were published in the Journal of the American Medical Association (JAMA).

Lilly continues to study donanemab in multiple clinical trials, including TRAILBLAZER-ALZ 3, which is focused on preventing symptomatic Alzheimer's disease in participants with preclinical AD; TRAILBLAZER-ALZ 5, a registration trial for early symptomatic AD currently enrolling in China and Korea; and TRAILBLAZER-ALZ 6, which is focused on expanding our understanding of ARIA through novel MRI sequences, blood-based biomarkers, and different dosing regimens of donanemab.

About Kisunla
Kisunla (donanemab for injection) (pronounced kih-SUHN-lah) is an amyloid-targeting therapy for people with mild cognitive impairment (MCI) as well as people with mild dementia stage of early symptomatic Alzheimer's disease, who are apolipoprotein E ε4 heterozygotes or non-carriers, with confirmed amyloid pathology. The treatment works 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

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.

Kisunla and its delivery device base are trademarks owned or licensed by Eli Lilly and Company, its subsidiaries, or affiliates.

SOURCE Eli Lilly Canada Inc.