Monoclonal Antibody Approved to Treat Alzheimer’s Disease in the United Arab Emirates

Eisai Co., Ltd. and Biogen Inc. announced that the Ministry of Health and Prevention in the United Arab Emirates (UAE) has approved humanized anti-soluble aggregated amyloid-beta monoclonal antibody LEQEMBI® (lecanemab) for the treatment of Alzheimer’s disease (AD).

LEQEMBI is the first approved treatment shown to reduce the rate of disease progression and to slow cognitive and functional decline through this mechanism. 

In the UAE, AD is considered the most common cause of dementia, typically accounting for 60-70% of cases. It is reported that 4.09% of people over 60 years old have dementia.

As of August 13, 2024, 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. 

Eisai has also submitted applications for approval of LEQEMBI in 11 countries and regions.

In the United States, a supplemental Biologics License Application for intravenous maintenance dosing was submitted to the U.S. FDA in March 2024 and was accepted in June 2024. The rolling submission of a Biologics License Application for maintenance dosing of a subcutaneous injection formulation, which is being developed to enhance patient convenience, was initiated in the U.S. under FDA Fast Track status in May 2024.