Eisai and Biogen have announced that their humanized anti-soluble aggregated amyloid-beta (Aβ) monoclonal antibody, LEQEMBI (lecanemab), has been approved by Israeli health authorities for the treatment of Alzheimer's disease (AD). The treatment is recommended for patients in the early stages of the disease, specifically those with mild cognitive impairment (MCI) or mild dementia, as demonstrated in clinical trials.
LEQEMBI works by selectively targeting and binding to both soluble Aβ aggregates (protofibrils) and insoluble Aβ aggregates (fibrils), which are key components of amyloid plaques in the brain. This action reduces the presence of both protofibrils and plaques, making LEQEMBI the first treatment of its kind to demonstrate a slowing of disease progression and a reduction in cognitive and functional decline through this mechanism. The drug has also been approved in the United States, Japan, China, South Korea, and Hong Kong, and is currently marketed in the United States, Japan, and China.
The approval in Israel is grounded on findings from the extensive global Phase 3 Clarity AD study. This study showed that LEQEMBI met its primary and all key secondary endpoints with statistically significant results.
Eisai leads the global development and regulatory submissions for lecanemab, with both Eisai and Biogen co-commercializing and co-promoting the product. Eisai holds the final decision-making authority and will handle the commercialization of LEQEMBI in Israel.
Protofibrils, considered the most toxic form of Aβ, are thought to play a significant role in the cognitive decline associated with Alzheimer's disease. These protofibrils cause neuronal damage, adversely affecting cognitive function through multiple pathways. This includes the formation of insoluble Aβ plaques and direct damage to brain cell membranes and neural connections. Reducing protofibrils is believed to mitigate neuron damage and slow the progression of Alzheimer's disease, thus preserving cognitive functions.
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