Eisai Co., Ltd. and Biogen Inc. jointly announced today that the Ministry of Food and Drug Safety in South Korea has given approval for the humanized anti-soluble aggregated amyloid-beta (Aβ) monoclonal antibody "LEQEMBI" (lecanemab) for treating adult patients with mild cognitive impairment due to Alzheimer’s disease (AD) or mild AD (early AD).

LEQEMBI specifically targets soluble Aβ aggregates (protofibrils) and insoluble Aβ aggregates (fibrils), major components of Aβ plaques in AD, thereby reducing both Aβ protofibrils and Aβ plaques in the brain. This makes LEQEMBI the first approved treatment shown to reduce the rate of disease progression and to slow cognitive and functional decline through this mechanism. South Korea becomes the fourth country to grant approval, following the U.S., Japan, and China.

In 2021, it was estimated that approximately 900,000 people in South Korea were dementia patients, with one in ten individuals over 65 suffering from dementia, and one in five from mild cognitive impairment (MCI). The average annual nursing care and medical costs per dementia patient are estimated to be 21.1 million KRW, rising to 33.1 million KRW for severe dementia patients.

Eisai leads LEQEMBI's development and regulatory submissions globally, with both Eisai and Biogen collaborating on commercialization and promotion, and Eisai having final decision-making authority. Eisai Korea Inc. will handle distribution and information provision activities in South Korea. Eisai is committed to working with healthcare professionals and other stakeholders to promote early diagnosis and treatment of AD.

LEQEMBI, developed through a strategic research alliance between Eisai and BioArctic, is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble (protofibril) and insoluble forms of amyloid-beta (Aβ). It is already approved in the U.S., Japan, and China.

The FDA approval of LEQEMBI was based on Phase 3 data from Eisai's Clarity AD clinical trial, showing significant reduction in clinical decline on the Clinical Dementia Rating Sum of Boxes (CDR-SB) and the AD Cooperative Study-Activities of Daily Living Scale for Mild Cognitive Impairment (ADCS-MCI-ADL) compared to placebo.

Eisai has submitted applications for LEQEMBI's approval in 13 countries and regions, including the European Union (EU). Additionally, a supplemental Biologics License Application (sBLA) for intravenous maintenance dosing was submitted to the U.S. FDA in March 2024, and a rolling submission of a Biologics License Application (BLA) for maintenance dosing of a subcutaneous injection formulation, under Fast Track status, was initiated in the U.S. in May 2024.

Eisai and Biogen have been collaborating on the joint development and commercialization of AD treatments since 2014, with Eisai leading the development and regulatory submissions globally. Similarly, Eisai and BioArctic have had a long-term collaboration since 2005, with Eisai obtaining global rights to study, develop, manufacture, and market lecanemab for the treatment of AD.

 

Source: acnnewswire.com

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