バイオジェン：FDAへBLA提出：Alzheimer’s Therapy（動画）」
Biogen: Submission of BLA to US FDA: Alzheimer’s Therapy：
Biogen：向美国FDA提交BLA：阿尔茨海默氏病治疗
2020年7月8日
バイオジェンとエーザイ：
本日、アルツハイマー病(AD)治療薬候補・アデュカヌマブについて、FDAへBiologics License Application（BLA）の提出が完了しました。
BLA申請の内容：
FDAとの継続的なコラボレーションによって、実現できたものです。
- 臨床第Ⅲ相試験
- EMERGE試験
- ENGAGE試験、
- 臨床第Ⅰb相試験 PRIME試験、
臨床データに基づいています。
優先審査を要請：
承認申請完了の一環として、Priority Review(優先審査)を要請しています。
承認された場合：
「アデュカヌマブはADの臨床症状の悪化を抑制する初めての治療法」となります。
また、「脳内アミロイドベータ（Aβ）の除去が、臨床結果の改善をもたらすことを実証した初めての治療法」となります。
EMERGE試験：
EMERGE試験（1,638人）では、アデュカヌマブの高用量投与群において、事前に規定した主要評価項目を達成しました。
Clinical Dementia Rating-Sum of Boxes （CDR-SB）：
投与78週におけるベースラインからの臨床症状悪化について、プラセボ投与群と比較して、統計学的に有意な抑制を示しました（22％抑制、P = 0.01）
https://www.biogen.co.jp/ja_JP/news-insights/japanaffiliatenews/2020-07-08-news2.html
Biogen Files With FDA for Approval of Alzheimer’s Therapy
Biogen Inc. said
it had submitted an application seeking U.S. clearance for its controversial Alzheimer’s disease therapy aducanumab, which if approved would be the first medicine available to slow the memory-wasting disease.
Shares of Biogen
jumped as much as 9.9% to $294.99 in New York trading. Biogen’s stock price has been closely tied to investors’ expectations for aducanumab over the past few years.
Biogen and its Japan-based partner Eisai Co.
asked for a priority review from the U.S. Food and Drug Administration,
the Cambridge, Massachusetts-based company said in a statement.
The agency has two months to accept or reject the application, with an accelerated review putting the medication on a path for a final decision by March 2021.
Aducanumab,
a so-called monoclonal antibody
designed to target amyloid plaque in the brain, has been one of the most closely watched drugs in development for several years.
Biogen at one point had halted research on it after getting disappointing results, only to revive the drug in a reversal that surprised many scientists and investors and raised the hopes of millions of patients and families.
Trials on Alzheimer’s Disease conference in San Diego
showed conflicting findings, with one trial suggesting the drug could be the first-ever to slow the progression of Alzheimer’s.
But a second, essentially identical trial showed no effect on the disease at all.
Aducanumab
is intended to combat the amyloid plaque that fills the brains of patients, the primary hallmark of the disease and long-believed to be responsible for the mental decline that comes with it.
Alzheimer’s
is a progressive disease that most commonly arises in people over age 60.
It robs patients of their memories and their minds, causing impaired speech and thought.
More than 5 million Americans are living with the disease, according to the most recent data from the U.S. Centers for Disease Control and Prevention, and more than 14 million are expected to suffer from it by 2060.
With no medications currently available to slow the progression of the disease, demand for a therapy like aducanumab would be substantial.
There are treatments that temporarily improve symptoms that generate billions of dollars in sales each year, even though they don’t offer long-lasting benefits.