Eisai files for approval of Leqembi in Japan

16 January 2023

Shares of Japanese drugmaker Eisai (TYO: 4523) were lifted by more than 3% to 8,327 yen this morning, after it revealed it has filed for domestic approval of its Alzheimer’s drug Leqembi (lecanemab), which was granted accelerated approval in the USA earlier this month.

The filing comes sooner than expected, as Eisai had only said it would do so by end-March. GlobalData forecasts strong global (8MM = USA, France, Germany, Italy, Spain, UK, Japan, and China) sales for lecanemab of $2.76 billion by 2030.

Along with partner Biogen (Nasdaq: BIIB), Eisai has submitted a marketing authorization application for lecanemab, an investigational anti-amyloid beta (Aβ) protofibril antibody for the treatment of mild cognitive impairment (MCI) due to Alzheimer’s disease (AD) and mild AD dementia (collectively known as early AD) with confirmed presence of amyloid pathology in the brain to the Pharmaceuticals and Medical Devices Agency (PMDA).

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