Biogen, Eisai: FDA Extends Review for Aducanumab Application

 The new Prescription Drug User Fee Act (PDUFA) action date set by the FDA is June 7, 2021

Biogen (Nasdaq: BIIB) and Eisai Co., Ltd. (Tokyo, Japan) today announced that the U.S. Food and Drug Administration (FDA) has extended the review period by three months for the Biologics License Application (BLA) for aducanumab, an investigational treatment for Alzheimer’s disease. The updated Prescription Drug User Fee Act (PDUFA) action date is June 7, 2021.

As part of the ongoing review, Biogen submitted a response to an information request by the FDA, including additional analyses and clinical data, which the FDA considered 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,” said Michel Vounatsos, Chief Executive Offer at Biogen. “We want to thank the FDA for its continued diligence during the review.”

Biogen submitted the aducanumab BLA to the FDA in July 2020. The FDA accepted the BLA in August 2020 and granted Priority Review.

https://www.globenewswire.com/news-release/2021/01/29/2166560/0/en/Biogen-and-Eisai-Announce-FDA-s-3-Month-Extension-of-Review-Period-for-the-Biologics-License-Application-for-Aducanumab.html