Recently NHK News on-line reported the following:
アルツハイマー病の新薬「レカネマブ」きょう承認審議 厚労省
2023年8月21日 6時09分
日本とアメリカの製薬会社が共同で開発したアルツハイマー病の新薬について厚生労働省は21日、専門家部会を開き、使用を認めるかどうか審議することにしています。認められれば、アルツハイマー病の原因物質に直接働きかけ、取り除くための初めての薬が国内で製造・販売できるようになります。
認知症の原因の1つである「アルツハイマー病」の新しい治療薬、「レカネマブ」は、日本の製薬大手「エーザイ」がアメリカの「バイオジェン」と共同で開発を進めてきた薬です。
アルツハイマー病の患者の脳にたまる「アミロイドβ」という、異常なたんぱく質を取り除くことで、症状の進行を抑えることが期待されています。
エーザイはことし1月に「レカネマブ」について、厚生労働省に承認を求める申請を行っていましたが、これを受けて厚生労働省は21日、専門家部会を開き、薬の使用を認めるかどうか審議することにしています。
「エーザイ」などの研究グループによりますと、最終段階の治験の結果では、この薬を投与された患者は、偽の薬を投与された患者と比べて1年半後の認知機能の低下がおよそ27％抑えられ、病状の進行を緩やかにする効果が確認されたということです。
アメリカでは先月上旬に治療薬として承認されていて、日本でも認められれば、アルツハイマー病の原因物質を取り除くための初めての薬が国内でも製造・販売できるようになります。
アルツハイマー病 日本では600万人と推計
アルツハイマー病は認知症の原因となる病気の1つで、日本では認知症と診断された高齢者の6割以上を占めています。
アルツハイマー病を発症した人の脳では、「アミロイドβ」と呼ばれる異常なたんぱく質がたまっていて、これにより神経細胞が壊れ、脳が委縮し、その結果、脳の働きが低下すると考えられています。
典型的な症状として初期に物忘れが目立ち、経過とともに理解や判断の力が衰えたり、身体的な機能も低下して動きが不自由になったりするなど、さまざまな症状が徐々に出てくるようになります。
厚生労働省によりますと、日本では認知症の人は3年前の時点で600万人と推計されていて、さらに団塊の世代が全員75歳以上の後期高齢者となる2025年には、およそ700万人にのぼると予測されています。
Translation
On the 21st, the Ministry of Health, Labor and Welfare would hold an expert subcommittee on a new drug for Alzheimer's disease that was jointly developed by Japanese and American pharmaceutical companies so as to decide whether to allow its use. If approved, it could be possible to manufacture and sell the first drug in Japan that worked directly on and removed the causative agent of Alzheimer's disease.
Lecanemab, a new drug for Alzheimer’s disease which was one of the causes of dementia, had been jointly developed by Japanese pharmaceutical giant Eisai and American company Biogen.
By removing the abnormal protein called "amyloid β" that accumulated in the brain of Alzheimer disease patients, it was expected to suppress the progression of symptoms.
Eisai applied for approval of ``Lecanemab'' to the Ministry of Health, Labor and Welfare in January this year. In response to this, the Ministry of Health, Labor and Welfare would hold an expert subcommittee on the 21st to discuss whether to approve the use of the drug.
According to research groups such as "Eisai", the results of the final-stage clinical trial showed that patients who received this drug had reduced about 27% cognitive declines after one and a half years compared to those who received a placebo, and the effect of slowing the progression of the disease was confirmed.
In the United States, it was approved as a therapeutic drug in early last month, and if it was approved in Japan, it would be possible to manufacture and sell in Japan as the first drug to remove the causative agent of Alzheimer's disease.
Alzheimer's disease estimated at 6 million people in Japan
Alzheimer's disease was one of the diseases that cause
dementia, and accounted for more than 60% of the elderly diagnosed with
dementia in Japan.
In the brains of people with Alzheimer's disease, an abnormal protein called "amyloid β" accumulated, it caused damage to nerve cells and shrank the brain, and was thought to cause decreased brain function as a result.
As a typical symptom, forgetfulness was noticeable in the early stages, and as time progressed the ability to understand and make decisions faded away, there would be a decline in physical function that caused difficulty in movement etc., various symptoms gradually appeared.
According to the Ministry of Health, Labor and Welfare, the number of people with dementia in Japan was estimated at 6 million as of three years ago, and by 2025 when all baby boomers became late-elderly aged 75 or older, it was predicted to reach approximately 7 million people.
So, Japan will hold an expert
subcommittee to discuss whether to allow the use of a new drug for Alzheimer's
disease jointly developed by Japanese and American pharmaceutical companies. In
the United States, it has been approved as a therapeutic drug last
month. It is good news for Japanese patients.
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