Eisai Co., Ltd. and Biogen Inc. are pleased to announce that the Ministry of Health and Prevention in the United Arab Emirates (UAE) has approved the humanized anti-soluble aggregated amyloid-beta (Aβ) monoclonal antibody “LEQEMBI®” (lecanemab) for the treatment of Alzheimer’s disease (AD). LEQEMBI is indicated for use in patients with mild cognitive impairment (MCI) or mild dementia, collectively referred to as early Alzheimer’s disease (AD), where treatment was initiated in clinical trials.

LEQEMBI is a groundbreaking treatment that selectively binds to soluble Aβ aggregates (protofibrils*), as well as insoluble Aβ aggregates (fibrils), major components of Aβ plaques. By reducing both Aβ protofibrils and Aβ plaques in the brain, LEQEMBI is the first approved treatment shown to slow the progression of Alzheimer’s disease and to reduce cognitive and functional decline through this mechanism. The approval in the UAE marks an important milestone in the global fight against Alzheimer’s, as the drug is also approved in the U.S., Japan, China, South Korea, Hong Kong, and Israel, with marketing ongoing in the U.S., Japan, and China.

The UAE’s approval of LEQEMBI is based on the results of the Phase 3 Clarity AD study, a large global clinical trial. The study met its primary endpoint and all key secondary endpoints with statistically significant results, reinforcing the effectiveness of LEQEMBI in slowing the progression of AD. In the UAE, approximately 4.09% of individuals over 60 years old are reported to have dementia, with Alzheimer’s disease being the most common cause, accounting for 60-70% of cases.

Eisai serves as the global lead for lecanemab development and regulatory submissions, with both Eisai and Biogen co-commercializing and co-promoting the product. In the UAE, Biogen will take the lead in commercializing LEQEMBI.