Mechanism of action and clinical trial results of Lecanemab (Leqembi<sup>®</sup> 200 mg, 500 mg for Intravenous Infusion), a novel treatment for Alzheimer’s disease
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- Niidome Tetsuhiro
- Eisai Co., Ltd.
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- Ishikawa Yukio
- Eisai Co., Ltd.
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- Ogawa Tomoo
- Eisai Co., Ltd.
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- Nakagawa Masaki
- Eisai Co., Ltd.
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- Nakamura Yosuke
- Eisai Co., Ltd.
Bibliographic Information
- Other Title
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- 新規アルツハイマー病治療薬レカネマブ(レケンビ<sup>®</sup>点滴静注200 mg,500 mg)の作用機序と臨床試験成績
Abstract
<p>Lecanemab is a humanized monoclonal antibody directed against human soluble amyloid-β aggregates. It was developed for the treatment of early Alzheimer’s disease (mild cognitive impairment or mild dementia stage of Alzheimer’s disease). Among the amyloid-β (Aβ) involved in Alzheimer’s disease, Lecanemab selectively binds to the highly neurotoxic Aβ protofibrils, and is thought to reduce Aβ protofibrils and amyloid plaques (Aβ plaques) in the brain. The efficacy and safety of Lecanemab in early Alzheimer’s disease were investigated in an international Phase II placebo-controlled study (Study 201) and an international Phase III placebo-controlled study (Study 301). Both studies included Japanese subjects. Lecanemab was given accelerated approval in the United States in January 2023, followed by traditional approval in July 2023. In Japan, it was approved for “control of the progression of mild cognitive impairment or mild dementia stage of Alzheimer’s disease” in September 2023, and was added to the NHI drug price list in December 2023.</p>
Journal
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- Folia Pharmacologica Japonica
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Folia Pharmacologica Japonica 159 (3), 173-181, 2024-05-01
The Japanese Pharmacological Society
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Details 詳細情報について
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- CRID
- 1390862943886123776
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- ISSN
- 13478397
- 00155691
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- Text Lang
- ja
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- Data Source
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- JaLC
- Crossref
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- Abstract License Flag
- Disallowed