Eisai seeks marketing nod for Lecanemab for early Alzheimer's disease treatment in South Korea
Lecanemab is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble (protofibril) and insoluble forms of amyloid-beta.
Tokyo: Eisai Co., Ltd. and Biogen Inc. have announced that Eisai has submitted a marketing authorization application for lecanemab (brand name in the U.S.: LEQEMBI), an investigational anti-amyloid beta (Aβ) protofibril* antibody, for the treatment of early Alzheimer’s disease (mild cognitive impairment due to Alzheimer’s disease (AD) and mild AD dementia) with confirmed amyloid pathology...
Tokyo: Eisai Co., Ltd. and Biogen Inc. have announced that Eisai has submitted a marketing authorization application for lecanemab (brand name in the U.S.: LEQEMBI), an investigational anti-amyloid beta (Aβ) protofibril* antibody, for the treatment of early Alzheimer’s disease (mild cognitive impairment due to Alzheimer’s disease (AD) and mild AD dementia) with confirmed amyloid pathology in the brain, to the Ministry of Food and Drug Safety (MFDS) in South Korea.
This application is the first application for lecanemab in Asia outside of Japan and China. Eisai plans to submit additional applications in other Asian countries.
The application is based on the results of the confirmatory Phase III Clarity AD study and Phase IIb clinical study (Study 201), which demonstrated that lecanemab treatment showed a reduction of clinical decline in early AD. Lecanemab selectively binds to and eliminates soluble, toxic Aβ aggregates (protofibrils) that are thought to contribute to the neurotoxicity in AD. As such, lecanemab may have the potential to have an effect on disease pathology and to slow down the progression of the disease. The Clarity AD study of lecanemab met its primary endpoint and all key secondary endpoints with highly statistically significant results.
"Eisai serves as the lead of lecanemab development and regulatory submissions globally with both Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority," the release stated.
Lecanemab is the result of a strategic research alliance between Eisai and BioArctic. Lecanemab is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble (protofibril) and insoluble forms of amyloid-beta (Aβ).
In the U.S., LEQEMBI was launched after being granted accelerated approval by the U.S. Food and Drug Administration (FDA) in January, 2023.
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