Biogen：向美国FDA提交BLA：阿尔茨海默氏病治疗
2020年7月8日
百健和卫材：
阿尔茨海默氏病（AD）候选药物Aducanumab的生物制剂许可申请（BLA）已于今天提交给FDA。
BLA应用程序详细信息：
通过与FDA的持续合作，使之成为可能。
III期临床试验
紧急测试
参与度测试
Ib期临床试验，PRIME研究，
根据临床数据。
要求优先审查：
在完成批准申请的过程中，我们要求进行优先审核。
如果获得批准：
“ Aducanumab是预防AD临床症状恶化的第一种治疗方法。”
这也是第一种证明去除脑淀粉样蛋白（Aβ）可以改善临床结果的治疗方法。
紧急测试：
在EMERGE试验（1,638例患者）中，高剂量阿德那单抗组达到了预先设定的主要终点。
临床痴呆症分级总和（CDR-SB）：
与安慰剂相比，在给药78周时从基线开始临床症状的统计学显着抑制（抑制率为22％，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.