FDA: Priority screening designation for Aducanumab: Alzheimer’s disease drug
August 7, 2020
Biogen and Eisai:
Today, we are pleased to inform you that Biogen’s Biologics License Application (BLA) has been accepted by the FDA for the drug candidate, Aducanumab, for Alzheimer’s disease (AD).
This application has been designated as a Priority Review.
PDUFA (Prescription Drugs User Fee Act):
The action date (target date for completion of examination) was set on March 7, 2021.
FDA has stated that it will complete the application early, if possible, under accelerated examination, if possible.
If approved by the FDA, “Aducanumab is the first treatment to prevent the worsening of clinical symptoms of AD.”
It is the first drug to demonstrate that removal of brain amyloid beta (Aβ) results in improved clinical outcomes.
2020 | Eisai Co., Ltd.
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.