Eisai Co., Ltd. and Biogen Inc. have jointly announced the upcoming launch of the humanized anti-soluble aggregated amyloid-beta (Aβ) monoclonal antibody, "LEQEMBI Intravenous Infusion" (200 mg, 500mg, 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, which 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), is set to become available in Japan, marking the second country after the United States.

Eisai and Biogen Japan will collaborate on promoting LEQEMBI in Japan, with Eisai serving as the Marketing Authorization Holder. The product's Optimal Clinical Use Guidelines have been agreed upon by the Central Social Insurance Medical Council, an advisory body of the Japanese Ministry of Health, Labour and Welfare.

LEQEMBI is a groundbreaking treatment that selectively binds to soluble amyloid-beta (Aβ) aggregates (protofibrils) and insoluble Aβ aggregates (fibrils), major components of Aβ plaques, thereby reducing both types in the brain. It is the first and only approved treatment demonstrating the ability to slow cognitive and functional decline by targeting this mechanism.

Haruo Naito, Chief Executive Officer at Eisai, emphasized the significance of launching LEQEMBI in Japan, where Eisai's value creation has commenced. Naito expressed the importance of establishing an optimal Alzheimer's disease diagnosis and treatment pathway through collaboration among various stakeholders.

Christopher A. Viehbacher, President and Chief Executive Officer of Biogen, highlighted the potential impact of LEQEMBI in providing additional valuable time for patients and their families, positioning Japan as a leader in elderly population care. The focus will be on engaging the medical community and supporting early diagnosis, recognizing its potential impact on disease progression.

Eisai will conduct a post-marketing special use results survey for all LEQEMBI-administered patients, in accordance with Ministry of Health, Labour and Welfare conditions. The promotion of appropriate LEQEMBI use, following guidelines and training materials for healthcare professionals, aims to manage and monitor amyloid-related imaging abnormalities (ARIA).

Eisai and Biogen remain committed to advancing early detection and diagnosis of AD, working towards early treatment, and contributing to the realization of a Dementia-Inclusive Society.

 

Source: eisai.com

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