FDA:アデュカヌマブを優先審査指定 ：アルツハイマー病治療薬（動画）：
FDA: Priority screening designation for Aducanumab: Alzheimer’s drug：
FDA：Aducanumab的优先筛查指定：阿尔茨海默氏病药物
2020年8月7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、バイオジェンによるBiologics License Application（BLA：生物製剤ライセンス申請）がFDAに受理されたことをお知らせします。
本申請は、優先審査(Priority Review）の指定を受けました。
PDUFA（Prescription Drugs User Fee Act）：
アクション・デート（審査終了目標日）は2021年3月7日に定められました。
FDAは、迅速審査のもと、可能であれば本申請について、早期に審査を完了する予定であると述べています。
FDAに承認された場合、「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。
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初めて実証した薬剤です。
2020年 | エーザイ株式会社
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.