Pharma Focus Asia

LEQEMBI® Scheduled for Launch in Japan for Alzheimer's Disease Treatment on December 20th

Wednesday, December 13, 2023

Eisai, the collaborator of BioArctic AB (Nasdaq Stockholm: BIOA B), has announced the forthcoming launch of LEQEMBI (lecanemab) in Japan on December 20. This follows its inclusion in the price listing on the Japan National Health Insurance (NHI) drug price list. LEQEMBI received manufacturing and marketing approval in Japan on September 25, 2023, for the indication of slowing the progression of mild cognitive impairment (MCI) and mild dementia due to Alzheimer's disease (AD).

With its scheduled inclusion in Japan's NHI drug price list, LEQEMBI is set to become available to Alzheimer's disease patients in Japan, making it the first disease-modifying treatment accessible to them. The product's Optimal Clinical Use Guidelines were also approved at a meeting of the Central Social Insurance Medical Council, an advisory body of the Japanese Ministry of Health, Labour and Welfare.

LEQEMBI is noteworthy for selectively binding to both soluble amyloid-beta (Aβ) aggregates (protofibrils) and insoluble Aβ aggregates (fibrils), which are major components of Aβ plaques in the brain. As the first and only approved treatment to demonstrate a reduction in the rate of disease progression and the slowing of cognitive and functional decline through this mechanism, LEQEMBI is making strides in Alzheimer's disease treatment.

Eisai, the lead in LEQEMBI's development and regulatory submissions globally, will conduct a post-marketing special use results survey for all LEQEMBI-administered patients in Japan until a specified amount of patient data is accumulated. This is in accordance with an approval condition imposed by the Ministry of Health, Labour and Welfare. Additionally, the appropriate use of LEQEMBI will be promoted based on the package insert and Optimal Clinical Use Guidelines, with training materials provided for healthcare professionals to manage and monitor amyloid-related imaging abnormalities (ARIA).

Gunilla Osswald, CEO of BioArctic, expressed enthusiasm, describing the launch as a "great Christmas present" that provides hope for Japan's aging population in need of new treatment options. While Eisai and Biogen co-commercialize and co-promote LEQEMBI globally, BioArctic retains the right to commercialize lecanemab in the Nordic region, pending European approval. Preparations for a joint commercialization in the region are currently underway.



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