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Biogen and Eisai submit aducanumab for FDA approval

By July 8, 2020Commentary, In the News

Contributed by Joshua Grill, PhD, Director of UCI MIND

This morning (July 8, 2020), Biogen and Eisai announced that the two companies had together completed submission to the FDA for regulatory and marketing approval of aducanumab, the monoclonal antibody against the beta amyloid protein that accumulates in the brain of people with Alzheimer’s disease.

We’ve previously written about the unique set of circumstances under which Biogen is submitting their application. Two large Phase 3 clinical trials were halted for futility in 2019, only for later assessments of the study data to lead to the sponsors to conclude that the drug achieved efficacy in slowing progression of Alzheimer’s disease, if adequately high doses were achieved.

Though mixed opinions remain about whether the FDA should approve aducanumab at this time, the submission of a new treatment entity for Alzheimer’s disease is nonetheless good news and an important milestone. It has been nearly two decades since a new drug was approved for Alzheimer’s disease and no approved drug can effectively slow or stop the debilitating progression of this fatal neurodegenerative disease. Regardless of the outcome of this specific submission, we hope that this marks the start of a new and exciting period in Alzheimer’s disease research — one with numerous promising candidate therapies achieve this milestone as well as approval and availability to the millions of people who so desperately need better treatment options.

About Joshua Grill, PhD:

Dr. Grill is an Associate Professor of Psychiatry & Human Behavior and Neurobiology & Behavior at UCI. He serves as Director of UCI MIND, Associate Director of the UCI Alzheimer’s Disease Research Center, and Leader of the Recruitment & Retention Unit for the UCI Institute for Clinical and Translational Science. His research focuses on clinical trials across the spectrum of Alzheimer’s disease, and he has published a number of important findings on trial design, recruitment and retention, and research ethics.