FDA：Aducanumab的优先筛查指定：阿尔茨海默氏病药物
2020年8月7日
百健和卫材：
今天，我们很高兴地宣布，FDA已批准Biogen的Biologics许可申请（BLA）用于Adukanumab（阿兹海默氏病（AD）的候选药物）。
该应用程序已被指定为优先审阅。
PDUFA（处方药使用者收费法）：
行动日期（完成考试的目标日期）设定为2021年3月7日。
FDA表示，如果可能，它将在可能的情况下尽早通过加速检查完成申请。
如果获得FDA的批准，“ Aducanumab是预防AD临床症状恶化的第一种治疗方法。”
这是第一种证明去除脑淀粉样蛋白（Aβ）可以改善临床结局的药物。
2020 |卫材株式会社
https://www.eisai.co.jp/news/2020/news202050.html
FDA Accepts Biogen’s Aducanumab Biologics License Application for Alzheimer’s Disease with Priority Review
Biogen Inc.
Eisai Co., Ltd.
CAMBRIDGE, Mass. and TOKYO,
August 7, 2020 (GLOBE NEWSWIRE) —
Biogen (Nasdaq: BIIB) and Eisai, Co., Ltd. (Tokyo, Japan) today
announced that the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for aducanumab, an investigational treatment for Alzheimer’s disease.
The application has been granted Priority Review, with a Prescription Drug User Fee Act (PDUFA) action date on March 7, 2021, and the FDA has stated that, if possible, it plans to act early on this application under an expedited review.
If approved, aducanumab would become the first therapy to reduce the clinical decline of Alzheimer’s disease and would also be the first therapy to demonstrate that removing amyloid beta resulted in better clinical outcomes.
“The FDA’s acceptance of the aducanumab BLA with Priority Review is an important step in the path to potentially having a treatment that meaningfully changes the course of Alzheimer’s disease,” said Michel Vounatsos, Chief Executive Officer at Biogen.
We look forward to working with the FDA throughout the review process and thank the thousands of clinicians, patients and caregivers who participated in our clinical trials and have accompanied us on this journey.
We believe that aducanumab marks the beginning of a new era of potential treatments for Alzheimer’s disease that will inspire even more discovery and innovation to bring hope to those affected by this devastating disease.
News Release：2020 | Eisai Co., Ltd.