Episode 39: A Controversial FDA Decision

Author(s):

"Mind Moments," a podcast from NeurologyLive, brings you an exclusive look into the FDA approval of aducanumab (Aduhelm; Biogen) for the treatment of Alzheimer disease.

For more insight and NeurologyLive coverage of aducanumab, click here.

Episode 39 of the NeurologyLive Mind Moments podcast is now live! Scroll down to listen or click here to subscribe on your favorite streaming service.

The Mind Moments podcast features exclusive interviews with leaders in the field discussing the latest research and disease management strategies across the breadth of neurology, including epilepsy, multiple sclerosis, Parkinson disease, dementia, sleep disorders, and more.

Episode 39, "A Controversial FDA Decision," features insights from a number of individuals in the Alzheimer disease space, including neurologists, psychiatrists, and advocacy partners who share their varying and nuanced opinions on this decision to better understand not only what this approval means for clinical care, but what the downstream effects of it may be. Those individuals, in order of appearance, are:

Marwan Sabbagh, MD, director, Cleveland Clinic Lou Ruvo Center for Brain Health, and investigator in the aducanumab trials
Anton P. Porsteinsson, MD, director, Alzheimer's Disease Care, Research and Education Program, University of Rochester School of Medicine and Dentistry, and investigator in the aducanumab trials
David Knopman, MD, professor of neurology, Mayo Clinic, and investigator in the aducanumab trials
Lon Schneider, MD, MS, professor of Psychiatry and the Behavioral Sciences, and Della Martin Chair in Psychiatry and Neuroscience, University of Southern California Keck School of Medicine
Robert Howard, MD, MRCPsych, Professor of Old Age Psychiatry, Faculty of Brain Sciences, University College London
Ian Kremer, JD, executive director, LEAD Coalition
Douglas Scharre, MD, neurologist and director, Division of Cognitive Neurology, Ohio State Wexner Medical Center

EPISODE BREAKDOWN

2:50 – Sabbagh's reaction to the FDA approval

4:50 – Porsteinsson on the impact on amyloid identification

7:55 – Knopman on the accelerated approval pathway

9:20 – Schneider on the FDA label for aducanumab

12:35 – Howard and Knopman on the utility of phase 4 data

14:20 – Porsteinsson on the potential of a multipronged approach

16:40 – Howard on the challenge of a multipronged approach

18:45 – Knopman on the impact on clinical development

21:35 – Kremer on access to aducanumab

24:25 – Scharre on the remaining need to identify patients earlier

27:55 – Kremer on what's still left to accomplish in Alzheimer