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"LEQEMBI® (Lecanemab) Receives Approval for Alzheimer's Disease Treatment in the United Arab Emirates"

NextEdge Admin

16 Aug 2024

2 min 28 sec

Eisai Co., Ltd. and Biogen Inc. announced that the Ministry of Health and Prevention in the United Arab Emirates (UAE) has approved LEQEMBI® (lecanemab), a humanized anti-soluble aggregated amyloid-beta (Aβ) monoclonal antibody, for the treatment of Alzheimer’s disease (AD). LEQEMBI is indicated for patients in the early stages of AD, specifically those with mild cognitive impairment (MCI) or mild dementia, which aligns with the population studied in clinical trials.

LEQEMBI works by selectively targeting and binding to both soluble Aβ aggregates (protofibrils) and insoluble Aβ aggregates (fibrils), the latter being a major component of Aβ plaques in the brain. This dual action leads to the reduction of both Aβ protofibrils and plaques. LEQEMBI is the first treatment approved that has been shown to slow the progression of AD and reduce cognitive and functional decline through this mechanism. The drug is also approved in the U.S., Japan, China, South Korea, Hong Kong, and Israel, and is currently marketed in the U.S., Japan, and China.

The approval in the UAE is based on data from the global Phase 3 Clarity AD study, in which LEQEMBI met its primary and all key secondary endpoints with statistically significant results. In the UAE, 4.09% of individuals over the age of 60 have dementia, with Alzheimer’s being the most common cause, accounting for 60-70% of cases.

Eisai leads the global development and regulatory submissions for lecanemab, with both Eisai and Biogen co-commercializing and co-promoting the drug. Biogen will handle commercialization in the UAE.