The Ministry of Health and Prevention in the United Arab Emirates (UAE) has approved Leqembi (lecanemab) an Alzheimer’s treatment – where 4.09% of those over 60 years old have dementia.
Leqembi’s approval in the UAE is based on a large global Phase 3 Clarity AD study in which Leqembi met its primary endpoint and all key secondary endpoints.
The treatment 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, and has also approved in the U.S., Japan, China, South Korea, Hong Kong, and Israel, and is now being marketed in the U.S., Japan, and China.
The treatment was developed as part of a long-standing collaboration between BioArctic and Eisai, with the antibody having been originally developed by BioArctic based on the work of Professor Lars Lannfelt and his discovery of the Arctic mutation in Alzheimer’s disease.
Eisai has also submitted applications for approval of lecanemab in 11 other countries and regions, including the European Union (EU).
A supplemental Biologics License Application (sBLA) for intravenous maintenance dosing was submitted to the U.S. Food and Drug Administration (FDA) in March 2024 and the rolling submission of a Biologics License Application (BLA) for maintenance dosing of a subcutaneous injection formulation, which is being developed to enhance convenience for patients, was initiated in the U.S. under Fast Track status in May 2024.