Second new drug for early Alzheimer’s disease is approved by Health Canada

Kisunla (donanemab for injection) is the second intravenous (IV) anti-amyloid beta monoclonal antibody for treatment of patients with early Alzheimer’s disease to be approved by Health Canada.1,2 The new product, which is anticipated to be marketed by Eli Lilly in mid-July 2026, follows the launch of Eisai’s Leqembi (lecanemab for injection) in December 2025.3 Key aspects of Leqembi were presented in the January/February 2026 drug news roundup. Key features of donanemab (Kisunla)Donanemab, like lecanemab, is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against insoluble N-truncated pyroglutamate amyloid beta, which is a component of dense, established amyloid beta plaque found in Alzheimer’s disease. Donanemab reduces amyloid beta plaque levels in the brain.1,4Donanemab and lecanemab are both indicated for the treatment of adults with a clinical diagnosis of mild cognitive impairment or mild dementia due to Alzheimer's disease. These drugs are intended for patients who are apolipoprotein E ε4 (ApoE ε4) heterozygotes or noncarriers, and who have confirmed amyloid pathology.1,3Donanemab will be supplied in a single-use vial containing donanemab 17.5 mg/mL (350 mg/20 mL). The recommended dosage schedule is as follows: Week 0–350 mg IV, Week 4–700 mg IV, Week 8–1,050 mg IV and Week 12 and beyond (to a maximum of 18 months)–1,400 mg IV. Treatment should be discontinued once amyloid plaque clearance is achieved, as no data are available on the safety or efficacy of continued donanemab treatment after amyloid clearance. In clinical trials, up to 60% of patients discontinued treatment before 18 months due to meeting amyloid clearance thresholds. Recommendations for dosing interruptions for patients who develop adverse effects (ARIA-E or ARIA-H, described below) are outlined in the product monograph.1Donanemab must be diluted with 0.9% sodium chloride injection to a final concentration of 4–10 mg/mL and infused over about 30 minutes. Patients should be observed for a minimum of 30 minutes post-infusion to evaluate for infusion and hypersensitivity reactions. Resuscitative equipment and rescue medications must be on hand.1The most common adverse effects of donanemab are increases in the risk of amyloid-related imaging abnormalities (ARIA) with edema or effusions (ARIA-E) and ARIA with hemorrhages or hemosiderin deposits (ARIA-H). Falls, headache, infusion-related reactions, arthralgia and superficial siderosis may also occur.1 ARIA-E and ARIA-H are the most serious adverse effects. Enhanced clinical vigilance for ARIA is recommended, especially during the first 24 weeks of treatment. ARIA is usually asymptomatic, but serious and even fatal ARIA events have occurred. Serious infusion-related reactions, including anaphylaxis have also been reported.1No drug interaction studies have been conducted with donanemab, but pharmacokinetic drug interactions are not expected. However, the drug is contraindicated in patients taking anticoagulants. Caution is required in administering thrombolytics, as fatal intracerebral hemorrhage has occurred in patients receiving donanemab who developed focal neurologic symptoms of ARIA and were treated with a thrombolytic agent.1Kisunla vials should be stored in a refrigerator (2°C–8°C) in the outer carton to protect from light, although they may be stored at room temperature (20°C–25°C) for up to three days.1Healthcare professionals should register all patients prescribed Kisunla in the Canadian Patient Registration Program (www.kisunlapatient.ca) to support appropriate patient selection, obtain access to educational materials on management of ARIA, and ensure patients carry a Patient Alert Card.1 Donanemab vs. lecanemabNo clinical trials are available comparing donanemab with lecanemab.4 Both drugs are considered to only modestly slow cognitive decline in patients with mild cognitive impairment or mild dementia due to Alzheimer’s disease. Neither drug stops or reverses cognitive decline, and both can cause serious, potentially fatal adverse effects.4 Direct comparisons of safety and efficacy data between the two pivotal phase 3 trials—CLARITY-AD (lecanemab) and TRAILBLAZER-ALZ2 (donanemab)—are not valid as the studies employed different biomarker and clinical inclusion/exclusion criteria, resulting in subtle but potentially meaningful differences in patient cohorts.5 In the absence of head-to-head randomized clinical trials, treatment decisions for individual patients will likely be decided by practical considerations (e.g., scheduling of infusions, payer coverage). Donanemab is administered IV every four weeks (over about 30 minutes), with escalating dose titration when initiating treatment, while lecanemab is given IV (over about 60 minutes) every two weeks.1,3-5 Donanemab is currently the only amyloid plaque-targeting therapy with evidence supporting stopping treatment once amyloid plaques are cleared.2,5Appropriate use of donanemab and lecanemabConsensus “appropriate use recommendations” for donanemab and lecanemab in real-world settings have been published.5,6 The documents outline appropriate patient selection; appropriate dosing, administration and monitoring; ARIA frequency, risk factors and monitoring, and management of ARIA, including serious and severe ARIA; management of infusion reactions; amyloid PET based discontinuation of treatment (for donanemab); switching to donanemab from another anti-amyloid beta monoclonal antibody; patient-centred, supported and shared decision-making processes; and needed clinical resources and workflow.5,6References:Eli Lilly Canada Inc. Kisunla (donanemab for injection) product monograph. Toronto, ON: April 30, 2026. (accessed May 7, 2026).Eli Lilly Canada Inc. Health Canada authorizes Lilly’s Kisunla (donanemab), a new treatment for early Alzheimer’s disease. May 4, 2026. (accessed May 7, 2026).Eisai Ltd. Leqembi (lecanemab for injection) product monograph. Mississauga, ON; October 24, 2025. (accessed May 7, 2026).Anon. Donanemab (Kisunla) for Alzheimer’s disease. Med Lett Drugs Ther 2024;66:129-31.Rabinovici GD, Selkoe DJ, Schindler SE, et al. Donanemab: appropriate use recommendations. J Prev Alzheimers Dis 2025;12(5):100150. (accessed May 7, 2026).Cummings J, Apostolova L, Rabinovici GD, et al. Lecanemab: appropriate use recommendations. J Prev Alzheimers Dis 2023;10(3):362-77. (accessed May 7, 2026).

Second new drug for early Alzheimer’s disease is approved by Health Canada

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