UAE approves Leqembi for treatment of Alzheimer's disease

Japan-based Eisai and US-based Biogen have announced that the Ministry of Health and Prevention in the United Arab Emirates (UAE) has approved the humanised monoclonal antibody LEQEMBI (lecanemab) for treating Alzheimer's disease (AD). 

LEQEMBI is intended for patients in the early stages of Alzheimer's, including those with mild cognitive impairment (MCI) or mild dementia, as identified in clinical trials. LEQEMBI works by selectively targeting both soluble amyloid-beta (Aβ) aggregates, known as protofibrils, and insoluble Aβ aggregates, which are the primary components of amyloid plaques in the brain. By reducing these protofibrils and plaques, LEQEMBI has been shown to slow the progression of the disease and decrease cognitive and functional decline.

It is the first treatment of its kind to be approved for this purpose. LEQEMBI has also received approval in the US, Japan, China, South Korea, Hong Kong, and Israel and is being marketed in the US, Japan, and China.

The UAE approval is based on data from the global Phase 3 Clarity AD study, where LEQEMBI successfully met its primary and secondary endpoints with statistically significant results. In the UAE, it is estimated that 4.09% of people over 60 years old have dementia, with Alzheimer's disease 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 sharing responsibilities for co-commercialising and promoting the product. In the UAE, Biogen will be responsible for marketing LEQEMBI.