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 (1/2)
2022年9月28日 18時30分
アルツハイマー病の新たな治療薬について、製薬大手の「エーザイ」は最終段階の治験の結果、症状の悪化を抑える効果が確認できたと発表しました。
会社は、来年3月末までに国内や欧米で承認申請を行うとしています。
「エーザイ」は28日、アメリカの製薬会社「バイオジェン」と共同で開発しているアルツハイマー病の新しい治療薬「レカネマブ」について、最終段階の治験の結果を発表しました。
それによりますと、治験は2019年3月からアメリカや日本、それにヨーロッパなどで軽度の認知症の患者や発症の前段階の患者、合わせておよそ1800人を対象に行われ、2週間に1回のペースで薬を投与するグループと偽の薬を投与するグループに分けて、医師などが評価する形で患者の認知機能の変化などを調べました。
その結果、投与から1年半たった時点で「レカネマブ」を投与したグループでは、症状の悪化が27％抑えられ、有効性が確認できたとしています。
「レカネマブ」は、アルツハイマー病の患者の脳にたまる異常なたんぱく質「アミロイドβ」に抗体を結合させて取り除くことで神経細胞が壊れるのを防ぎ、病気の進行そのものを抑えることを目的としています。
会社では、詳しい解析結果をことし11月にアメリカで開催される認知症の学会で報告するほか、来年3月末までにアメリカと日本、それにEUで承認申請を行うとしています。
アルツハイマー病の新たな治療薬「レカネマブ」について、開発を進める製薬大手の「エーザイ」は28日、東京都文京区の本社で会見を開き、来年3月末までに国内や欧米で承認申請を行うとする方針を示しました。
「エーザイ」の内藤晴夫CEOは会見で「今回の治験の成功は認知症治療における大きな前進で、承認後は介護負担の低減など前向きなインパクトを社会にもたらすと期待している。薬を待つ人たちのためにいち早く届けられるように全力を尽くしていきたい」と話しました。
治療薬「レカネマブ」とは
「レカネマブ」は、製薬大手の「エーザイ」がアメリカの製薬会社「バイオジェン」と共同でアルツハイマー病の治療薬として開発を進めてきました。
アルツハイマー病の治療薬は、これまで神経細胞に作用するなどして症状が悪化するのを遅らせるものはありましたが、国内では病気の進行そのものを抑える薬で承認されているものはありません。
ただ、壊れてしまった神経細胞を再生させることはできないため、発症する前の「軽度認知障害」の段階や、発症後、早期に投与することが重要だとしています。
(to be continued)
Translation
Eisai, a major pharmaceutical company, announced that the results of final-stage clinical trials of a new treatment for Alzheimer's disease had confirmed its effective in suppressing the worsening of symptoms.
The company planned to apply for approval in Japan, Europe
and the United States by the end of March next year.
On the 28th, Eisai announced the results of the final stage
clinical trial of "Lecanemab", a new treatment drug for Alzheimer's
disease, which was being jointly developed with an American pharmaceutical
company Biogen.
According to it, the clinical trial was conducted from March 2019 in the United States, Japan, Europe, etc., with a total of about 1,800 patients with mild dementia and patients in the pre-onset stage. It was administered at a pace of once every two weeks to patients divided into a group, one administered the medicine and then other administered a placebo, and changes in the cognitive function of patients were examined by doctors in the form of evaluation.
As a result, in the group that received “Lecanemab”, one and
a half years after administration, the worsening of symptoms was suppressed by
27%, its efficacy was confirmed.
"Lecanemab" aimed to suppress the progression of the disease itself by binding antibodies to the abnormal protein "Amyloid β" that accumulated in the brains of Alzheimer's disease patients and then to remove it so as to prevent nerve cell damage.
The company would report detailed analysis results at a dementia conference to be held in the United States in November, and would apply for approval in the United States, Japan, and the EU by the end of March next year.
Eisai, a major pharmaceutical company that was developing a
new treatment drug “Lecanemab” for Alzheimer's disease, held a press conference
at its headquarters in Bunkyo-ku, Tokyo on the 28th, showing a policy to apply
for approval in Japan, Europe and the United States by the end of March next
year.
Haruo Naito, CEO of Eisai, said at a press conference that "The
success of this clinical trial is a major step forward in the treatment of
dementia, and after its approval we expect it to have a positive impact on the society,
such as reducing the burden of nursing care. For the people waiting for the
drug, I would like to do my best so that it can be delivered as soon as
possible."
On that basis, about the future, detailed analysis results
at the dementia conference to be held in the United States in November this year
would be reported, and approval in the United States, Japan, and the EU would
be applied by the end of March next year, indicating a policy aiming for
approval within the next year.
What was the therapeutic drug “Lecanemab”?
Lecanemab had been developed as a treatment for Alzheimer's
disease by Eisai, a major pharmaceutical company, in collaboration with the
American pharmaceutical company Biogen.
In the brains of patients with Alzheimer's disease, an
abnormal protein called "Amyloid beta" accumulated, and it was
believed that this caused the destruction of nerve cells.
"Lecanemab" was intended to remove "Amyloid β" by binding it to an artificially produced antibody and removed it at the stage before it solidified, and it was expected to have the effect of preventing the destruction of nerve cells and suppressing the progression of the disease itself.
However, since it was not possible to regenerate damaged
nerve cells, it is important to administer it at the stage of "mild
cognitive impairment", and at an early stage after the onset of symptoms.
(to be continued)
