(RTTNews) - Biogen Inc. (BIIB) and Japan-based Eisai Co., Ltd. said Friday that the U.S. Food and Drug Administration or FDA has extended the review period for the Biologics License Application (BLA) for aducanumab by three months. Aducanumab is an investigational treatment for Alzheimer's disease.
The updated Prescription Drug User Fee Act or PDUFA action date is June 7, 2021, the companies noted.
Biogen said that as part of the ongoing review, it submitted a response to an information request by the FDA, including additional analyses and clinical data. The FDA considered this as a major amendment to the application that will require additional time for review.
"We are committed to working with the FDA as it completes its review of the aducanumab application. We want to thank the FDA for its continued diligence during the review," said Michel Vounatsos, Chief Executive Offer at Biogen.
Biogen licensed aducanumab from Neurimmune under a collaborative development and license agreement. Since October 2017, Biogen and Eisai have collaborated on the development and commercialization of aducanumab globally.
Biogen submitted the aducanumab BLA to the FDA in July 2020. The FDA accepted the BLA in August 2020 and granted Priority Review.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
