Canada's Drug Agency issues final positive recommendation supporting public reimbursement of Leqembi®
Canada's Drug Agency issues final positive recommendation supporting public reimbursement of Leqembi® |
| [01-September-2026] |
STOCKHOLM, September 1, 2026 /PRNewswire/ -- BioArctic AB's (publ) (STO: BIOA B) partner Eisai announced today that Canada's Drug Agency (CDA-AMC) has issued a final recommendation supporting public reimbursement of Leqembi (lecanemab) for eligible patients in Canada with mild cognitive impairment (MCI) or mild dementia due to Alzheimer's disease (early AD). The final recommendation follows a reconsideration by CDA-AMC and represents an important step toward broadening access to Leqembi in Canada. Next steps include negotiations through the pan-Canadian Pharmaceutical Alliance, followed by reimbursement decisions by public drug plans across Canada's provinces and territories. More than 770,000 people in Canada were estimated to be living with dementia in 2025, and that number is projected to increase to 1.7 million by 2050.[1] The information was released for public disclosure, through the agency of the contact person below, on September 1, 2026, at am 07:00 CEST. For further information, please contact: Leqembi is approved in 53 countries and is under regulatory review in 6 countries. Following the initial phase with treatment every two weeks for 18 months, intravenous (IV) maintenance dosing with treatment every four weeks is approved in 8 countries, including the United Kingdom, China, the US and Japan, and applications have been filed in 12 countries and regions. In the US, Leqembi Iqlik® is approved for subcutaneous dosing with an autoinjector as a starting dose and maintenance treatment of early Alzheimer's disease. In November 2025, a new drug application for subcutaneous formulation of Leqembi for initiation treatment was submitted in Japan. In December 2025, Leqembi was included in the "Commercial Insurance Innovative Drug List", recently introduced by the National Healthcare Security Administration (NHSA) of China. In January 2026, the Biologics License Application for subcutaneous formulation of Leqembi was accepted in China and in February, the application was designated for priority review. Since July 2020, Eisai's Phase 3 clinical study (AHEAD 3-45) with lecanemab in individuals with preclinical Alzheimer's disease meaning they are clinically normal and have intermediate or elevated levels of amyloid in their brains, is ongoing. The study was fully recruited in October 2024. AHEAD 3-45 is a four-year study conducted as a public-private partnership between Eisai, Biogen and the Alzheimer's Clinical Trial Consortium that provides the infrastructure for academic clinical trials in Alzheimer's disease and related dementias in the US, funded by the National Institute on Aging, part of the National Institutes of Health. Since January 2022, the Tau NexGen clinical study for Dominantly Inherited Alzheimer's disease (DIAD), that is conducted by Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU), led by Washington University School of Medicine in St. Louis, is ongoing and includes lecanemab as the backbone anti-amyloid therapy. About the collaboration between BioArctic and Eisai About BioArctic AB [1] Alzheimer Society of Canada. "Dementia numbers in Canada". Available at: https://alzheimer.ca/en/about-dementia/what-dementia/dementia-numbers-canada. Last accessed: August 20, 2026. This information was brought to you by Cision http://news.cision.com The following files are available for download:
SOURCE BioArctic | ||||
Company Codes: Stockholm:BIOAB,ISIN:SE0010323311,RIC:BIOAb.ST,Bloomberg Code:BIOAB@SS |
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