Recently NHK News on-line reported the following:
アルツハイマー病の新薬 “症状悪化抑える効果確認” エーザイ (2/2)
2022年9月28日 18時30分
アルツハイマー病の治療薬 開発の歩み
アルツハイマー病の治療薬として使われている薬は4種類ありますが、国内では新薬の承認は2011年以来ありません。
現在使われている薬はアルツハイマー病の症状を緩和したり悪化するのを遅らせたりするもので、脳の神経細胞が失われるのを防いで、病気の進行そのものを抑える薬はありませんでした。
その中で、製薬大手の「エーザイ」とアメリカの製薬会社「バイオジェン」は、アルツハイマー病の進行そのものを抑える目的で、今回の「レカネマブ」とは別の抗体医薬「アデュカヌマブ」の開発を進めてきました。
「アデュカヌマブ」について、アメリカのFDA＝食品医薬品局は去年6月、患者の脳内にたまる異常なたんぱく質「アミロイドβ」を減らす効果があるとして、深刻な病気の患者に早期に治療を提供するために設けられた「迅速承認」という制度のもとで、条件付きで承認しました。
また、ヨーロッパ医薬品庁も「全体としては治療に効果があると示されていない」として承認しないよう勧告し、製薬会社が申請を取り下げています。
さらに、日本の厚生労働省の専門家部会でも有効性を明確に判断するのは困難だとして、承認するかどうか判断せず、改めて審議するとしています。
アルツハイマー病の根本的な治療法がないなか、病気の進行そのものを抑えることを目的に開発が進められた今回の「レカネマブ」は最終段階の治験で有効性が示されるか、患者や専門家から注目が集まっていました。
専門家「次の時代に向けた非常に大きなステップ」
製薬大手「エーザイ」などが開発を進めるアルツハイマー病の治療薬「レカネマブ」について、日本認知症学会の理事長で、東京大学の岩坪威教授は「今回の治験結果は『アミロイドβ』に対する抗体医薬がはっきりと有効性を示した最初の例になる。『アミロイドβ』をターゲットとする治療法が一定の条件を満たす場合には確かに有効であると言えたのではないかと思う」と評価しました。
そして「これまでの薬は、症状を改善させる薬で、病気自体が進行していく過程に効果を及ぼすものでなかったが、今回は、脳の中の異常なたんぱく質がたまっていくのを防いで取り除く薬で、病気そのものに歯止めをかけていくものだ。まだすべての認知症の方をカバーできる薬ではないが、次の時代に向けた非常に大きなステップになると思う」と述べました。
そのうえで「今後、さらに有効性の高い治療法やほかのターゲットに対する治療法の開発が加速する非常に大きなきっかけになると期待している。日本が認知症の医療や研究でリーダーシップをとっていく1つのきっかけになればと思う」と話していました。
認知症の当事者などの団体「待ち望んでいた」
アルツハイマー病の新たな治療薬「レカネマブ」の有効性が確認されたとする治験結果が発表されたことについて、認知症の当事者や家族などでつくる団体からは歓迎する声が上がっています。
全国およそ1万人の会員でつくる公益社団法人「認知症の人と家族の会」の鈴木森夫代表理事は28日、都内の看護学校で認知症への対応力を学ぶ講座の講師を務めました。
この中で「レカネマブ」の治験結果について紹介した鈴木代表理事は、「アルツハイマー病の患者はますます増え、若年性で30代ぐらいから発症する人もいる中、初期の段階でしっかり治療できる薬は皆が待ち望んでいたもので本当に喜びたい」と話していました。
また、講義のあとNHKの取材に答えた鈴木代表理事は「“不治の病”と言われるアルツハイマー病でも治る可能性があるという光が今回の治験の結果で見えたことの意味は大きい。認知症を根本から治療できる薬の実現を多くの人が期待している一方で今回の薬は早期のアルツハイマー病が対象だということで、症状が進んだ人たちにどこまで薬の効果が見込まれるかは気になるところだ。認知症にはさまざまな症状があるため、さらなる薬の開発が必要なのはもちろん、認知症になっても安心して暮らせる環境づくりが引き続き重要だ」と話していました。
Translation
(continue)
History of Development of Drugs for Alzheimer's Disease
There were four types of drugs used to treat Alzheimer's
disease, but no new drugs had been approved in Japan since 2011.
The drugs currently in use eased the symptoms of Alzheimer's disease or delay the deterioration, and there was no drug that prevented the loss of nerve cells in the brain and suppressed the progression of the disease itself.
Against this backdrop, major pharmaceutical company Eisai together
with American pharmaceutical company Biogen had been developing an antibody
drug, “Aducanumab”, which was different from “Lecanemab”, with the aim of
suppressing the progression of Alzheimer's disease itself.
Regarding "Aducanumab", the US FDA = Food and Drug
Administration announced in June last year that it had the effect of reducing
the abnormal protein "Amyloid β" that accumulated in the patient's
brain, and had approved it conditionally under the system of "accelerated
approval" in order to provide early treatment to patients with serious
illness.
However, the drug had been disputed by experts, who said that the drug did not show consistent data in showing its efficacy in the final stage clinical trials, and in the insurance for the elderly which was also called "Medicare" in the United States, the drug was not approved for use except in patients participating in certain clinical trials.
Also, the European Medicines Agency had recommended not to approve it as ``it has not been shown to be effective for treatment as a whole'', and pharmaceutical companies had withdrawn their applications.
In addition, the expert subcommittee of the Ministry of Health, Labor and Welfare in Japan also said that it would be difficult to clearly judge the effectiveness, so it will not decide whether to approve it or not, and would deliberate it again.
In the absence of a fundamental treatment for Alzheimer's disease, Lecanemab, which was developed with the aim of suppressing the progression of the disease itself, whether it could show effective in final-stage clinical trials was getting attention from patients and experts.
Experts: 'Very big step towards the next era'
About Lecanemab, an Alzheimer's disease drug being developed
by major pharmaceutical company Eisai, etc., Professor Takeshi Iwatsubo of the
University of Tokyo and chairman of the Japanese Society for Dementia said,
``The results of this clinical trial show that antibody drugs against 'amyloid
is effective, a first example that clearly demonstrated this. I think we can
say that a treatment that targets 'Amyloid β' is certainly effective if certain
conditions are met."
Then it was said that "Previously, drugs were meant to
improve symptoms and had no effect on the progression of the disease itself, yet
this time, it is a drug that prevents and removes the accumulation of abnormal
proteins in the brain, and puts a brake on the disease itself. It is not yet a
drug that can cover all dementia patients, but I think it will be a very big
step towards the next era."
Also, Professor Iwatsubo in commenting the impact on future
treatment of Alzheimer's disease, said that if it were put into practical use,
the cost of the drug might be high at first, “if we take necessary action
against anticipated situations, we can reduce the number of people with
advanced symptoms, the expectations that we will be able to save effort and
money spent on nursing care may increase. In the future, I believe that
pharmaceutical companies will apply for approval in Japan and overseas if
steady progress is made, there is a possibility that it will be approved as a
drug in Japan next year.”
On top of that he said, "In the future, I expect that it will be a very big opportunity to accelerate the development of even more effective treatments and treatments for other targets. I hope this will be an opportunity for Japan to take leadership in dementia care and research."
Groups of people with dementia etc. - "we were
waiting"
Groups made up of people with dementia and their families
welcomed the announcement of the results of a clinical trial that confirmed the
effectiveness of a new drug for Alzheimer's disease.
Morio Suzuki, Representative Director of a public interest incorporated
association the "Association for People with Dementia and Their
Families", which is made up of about 10,000 members nationwide, would be a
speaker on the 28th at a nursing school in Tokyo in knowing about how to deal
with dementia.
In that, representative Director Suzuki, who introduced the
clinical trial results of “Lecanemab” said, ``The number of Alzheimer's disease
patients is increasing, and some people are young and develop symptoms in their
30s, everyone has been waiting for a drug that can treat it in an early stage,
and I am really happy about it.”
In an interview with NHK after the lecture, Representative
Director Suzuki said, "It is very significant that the results of this
clinical trial have shown that even Alzheimer's disease, which is said to be an
incurable disease, can be cured. While many people are hoping for a drug that
can treat the root cause of Alzheimer's disease, it is a matter of concern as to
what extent the drug is expected to be effective for people with advanced
symptoms. Since dementia has various symptoms, it is necessary to develop
further drugs, and it is also important to create an environment where people
with dementia can live with peace of mind."
So, a
major pharmaceutical company has announced the result of a final-stage
clinical trial on a drug for Alzheimer's disease and confirms that the drug is
effective. Until now, Alzheimer's disease drugs have been able to delay the
worsening of symptoms while "Lecanemab" is expected to have the
effect of preventing the destruction of nerve cells and suppressing the
progression of the disease itself. This is good news for all Alzheimer
patients.
沒有留言:
張貼留言