Pharma Focus Asia
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Eisai and Biogen Announced the Approval of LEQEMBI® in Japan

Monday, September 25, 2023

Eisai Co and Biogen have recently announced the approval of LEQEMBI® Intravenous Infusion (lecanemab) in Japan for the treatment of mild cognitive impairment (MCI) and mild dementia due to Alzheimer's disease (AD). 

LEQEMBI is a significant advancement in Alzheimer's disease treatment as it represents the first and only approved therapy that has demonstrated the ability to reduce the rate of disease progression and slow cognitive and functional decline in affected individuals.

LEQEMBI is a humanised monoclonal antibody of the IgG1 class, specifically designed to target and neutralise aggregated soluble forms of amyloid-beta (Aβ), including protofibrils, as well as insoluble Aβ. These aggregated Aβ species are known to be highly toxic and contribute to the neurotoxicity observed in AD. By selectively binding to and eliminating these toxic Aβ aggregates, LEQEMBI aims to mitigate the progression of the disease and alleviate cognitive and functional impairments.

The approval of LEQEMBI is based on robust clinical trial data, including the successful outcomes of the Phase 3 Clarity AD trial, which demonstrated its effectiveness in slowing the progression of AD and improving the lives of those affected by the disease.

This approval marks a significant milestone in the treatment of Alzheimer's disease, offering hope for individuals living with this progressive and debilitating condition.

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