#Canada #Ontario #Leqembi #BioArctic #Alzheimer’s Disease

Health Canada Approves Leqembi® for Alzheimer’s Treatment

Health Canada has officially authorized Leqembi® (lecanemab), a groundbreaking treatment developed by BioArctic AB and its partner Eisai, for patients diagnosed with mild cognitive impairment or mild dementia due to Alzheimer's disease. This marks a significant advancement in the fight against Alzheimer's, as Leqembi® is specifically approved for those who are apolipoprotein E ε4 (ApoE ε4) non-carriers or heterozygotes and have confirmed amyloid pathology.

A Milestone in Alzheimer's Treatment

Leqembi® is celebrated as the first treatment targeting the underlying mechanisms of Alzheimer's disease (AD) to receive approval in Canada, representing a major breakthrough in the management of this debilitating condition. The therapy functions by selectively binding to both soluble Aβ aggregates (protofibrils) and insoluble forms that contribute to the formation of Aβ plaques, thereby minimizing their presence in the brain. As confirmed by robust Phase 3 clinical trials, Leqembi® not only demonstrates the ability to reduce amyloid plaques but is also the first approved drug proven to slow the progression of AD.

Leading the charge against the devastating impacts of Alzheimer's, Leqembi® holds approval from 51 countries and regions, including major markets such as Japan, the United States, and the European Union. Furthermore, additional applications for approval are currently pending in nine other countries.

Backed by Strong Clinical Evidence

The foundation for Leqembi®'s approval lies in the large Phase 3 Clarity AD study. This pivotal research successfully met its primary endpoints and crucial secondary endpoints, showcasing statistically significant improvements in patients' cognitive functions. The authorization from Health Canada, however, comes with conditions that necessitate further trials to substantiate the clinical benefits of Leqembi®. Eisai plans to gather and submit real-world clinical data to support ongoing product evaluation.

The Growing Burden of Alzheimer’s Disease

Alzheimer's disease represents the most prevalent form of dementia, accounting for 60-80% of all dementia cases. As of January 2025, Canada is home to over 771,000 individuals living with dementia, with projections suggesting that this number will rise to nearly one million by 2030 and may ultimately exceed 1.7 million by 2050. The burden of caregiving is also substantial; the care provided by family and friends is equivalent to 290,000 full-time jobs – a figure expected to escalate to 690,000 by 2050.

A Collaborative Effort

Leqembi® is the result of an enduring partnership between BioArctic and Eisai, building on initial research led by Professor Lars Lannfelt, who identified the Arctic mutation linked to Alzheimer's disease. Eisai has been instrumental in the clinical development and commercialization strategy for this innovative treatment, while BioArctic retains rights for commercialization within the Nordic region, highlighting a collaborative approach to tackling Alzheimer's disease.

The release of this information was made public by BioArctic through its communications office. For those interested in further details about this remarkable healthcare advancement, please reach out to Oskar Bosson, Vice President Communications and Investor Relations.

By receiving regulatory approval, Leqembi® not only paves the way for improved management of Alzheimer's disease but also symbolizes hope for millions affected by this challenging condition. With continuing support and research, the battle against Alzheimer's disease enters a new chapter.