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South Korea Drug approvals | Updates | MFDS | iPharmaCenter

Updated: Jun 26, 2023

Eisai submitted a marketing authorization application to South Korea's Ministry of Food and Drug Safety (MFDS) to seek approval for lecanemab (known as Leqembi in the U.S.), an investigational anti-amyloid beta (Aβ) protofibril antibody.

The application seeks approval for using lecanemab to treat early Alzheimer's disease, explicitly targeting mild cognitive impairment and mild dementia associated with Alzheimer's disease in individuals with confirmed amyloid pathology in the brain. This is the first application for lecanemab in Asia outside of Japan and China, and Eisai plans to submit additional applications in other Asian countries.

The marketing authorization application is based on the results of two clinical studies: the Phase III Clarity AD study and the Phase IIb clinical study (Study 201). These studies demonstrated that lecanemab treatment reduced clinical decline in individuals with early Alzheimer's.

Lecanemab specifically binds to and eliminates soluble, toxic Aβ aggregates called protofibrils, which are believed to contribute to the neurotoxicity associated with Alzheimer's disease. By targeting these protofibrils, lecanemab has the potential to impact disease pathology and slow down disease progression. The Clarity AD study met its primary and secondary endpoints, yielding highly statistically significant results.

Eisai is leading the development and regulatory submissions for lecanemab globally, and both Eisai and Biogen will co-commercialize and co-promote the product. Eisai will have final decision-making authority in these matters.



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