“Whatever happens we’re going to learn a ton about drug development and how the FDA views these things by what happens to aducanumab.”

In early July, Biogen announced that it had completed and submitted a biologics license application (BLA) for its investigational agent aducanumab for the treatment of Alzheimer disease (AD). If approved, aducanumab would become the first treatment for the reduction of clinical decline in Alzheimer, as well as the first to demonstrate clinical benefit through amyloid-beta removal.

Aducanumab was also listed among the more notable agents within Jeffrey Cummings, MD, ScD, and colleagues’ 2020 AD systematic pipeline review. Cummings, who is the director emeritus of the Lou Ruvo Center for Brain Health at Cleveland Clinic and vice chair of the Department of Brain Health at the University of Nevada-Las Vegas, understands the landscape-altering magnitude the possible approval of aducanumab could have with its upcoming FDA decision.

In an interview with NeurologyLive, Cummings details his knowledge of the Biogen agent, its history thus far in its clinical development, and what is on the horizon for the drug going forward.
Biogen Completes Submission of Biologics License Application to FDA for Aducanumab as a Treatment for Alzheimer’s Disease [press release]. Cambridge, MA. Biogen. Published July 8, 2020. Accessed July 8, 2020. globenewswire.com/news-release/2020/07/08/2059186/0/en/Biogen-Completes-Submission-of-Biologics-License-Application-to-FDA-for-Aducanumab-as-a-Treatment-for-Alzheimer-s-Disease.html