Stockholm, Sweden, August 14, 2024 – BioArctic AB’s (publ) (Nasdaq Stockholm: BIOA B) partner Eisai announced today that the Ministry of Health and Prevention in the United Arab Emirates (UAE) has approved Leqembi® (lecanemab) for the treatment of Alzheimer’s disease (AD).
Treatment with Leqembi should be initiated in patients with mild cognitive impairment (MCI) or mild dementia stage of disease (collectively referred to as early AD), the population in which treatment was initiated in clinical trials.
Leqembi’s approval in the UAE is based on the large global Phase 3 Clarity AD study. In the Clarity AD study, Leqembi met its primary endpoint and all key secondary endpoints with statistically significant results.[1] In the UAE, it is reported that 4.09% of those over 60 years old have dementia.[2] AD is considered the most common cause of dementia, typically accounting for 60-70% of cases.[3]
Leqembi selectively binds to soluble amyloid-beta (Aβ) aggregates (protofibrils[4]), as well as insoluble Aβ aggregates (fibrils) which are a major component of Aβ plaques in AD, thereby reducing both Aβ protofibrils and Aβ plaques in the brain.
Leqembi is the first approved treatment shown to reduce the rate of disease progression and to slow cognitive and functional decline through this mechanism. Leqembi is also approved in the U.S., Japan, China, South Korea, Hong Kong, and Israel, and is being marketed in the U.S., Japan, and China.
Leqembi is the result of a long-standing collaboration between BioArctic and Eisai, and the antibody was originally developed by BioArctic based on the work of Professor Lars Lannfelt and his discovery of the Arctic mutation in Alzheimer’s disease.
Eisai is responsible for the clinical development, applications for market approval and commercialization of Lecanemab for Alzheimer’s disease. Eisai’s partner Biogen will commercialize Leqembi in the UAE. BioArctic has the right to commercialize lecanemab in the Nordic region and pending European approval Eisai and BioArctic are preparing for a joint commercialization in the region.
