Biogen’s Alzheimer’s Drug Candidate Gets FDA Review Extension

Biogen and Eisai have announced that the 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 new action date is June 7, 2021. If approved, aducanumab would be the first treatment to meaningfully change the course of the disease for individuals living with Alzheimer’s disease.

As part of the ongoing review of aducanumab, 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. Biogen submitted the aducanumab BLA to the FDA in July 2020. The FDA accepted the BLA in August 2020 and granted Priority Review.

Aducanumab is an investigational human monoclonal antibody studied for the treatment of Alzheimer’s disease. Based on clinical data from patients with Mild Cognitive Impairment due to Alzheimer’s disease and mild Alzheimer’s disease, aducanumab has the potential to impact underlying disease pathophysiology, slow cognitive and functional decline and provide benefits on patients’ ability to perform activities of daily living.

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. (Source: Biogen Website, 29 January, 2021)