Should the FDA Approve aducanumab to Treat Alzheimer’s? (Approved)
Experts disagree and the FDA’s own advisory committee says “No.”
UPDATE June 7, 2021: The Food and Drug Administration today approved the drug aducanumab, marking the agency’s first approval of a medication for Alzheimer’s disease since 2003. The controversial drug was developed by Biogen under the name Aduhelm and was approved on the FDA’s fast-track program, Accelerated Approval.
Read today’s statement from the FDA. Scroll down for more about the controversies regarding the drug’s clinical trials and the efficacy of the now-approved drug.
On June 7, 2021, the FDA is expected to rule whether it will approve a new treatment for Alzheimer’s with a curious name — aducanumab. The drug, developed by Biogen, is administered intravenously and has created controversy within the Alzheimer’s community.
Alzheimer’s experts disagree, and the FDA’s independent advisory committee has advised against approval. Patient advocacy groups in the main support approval of the drug, including the Alzheimer’s Association (see link below to its October 23, 2020, letter to the FDA’s Advisory Committee).
Critics argue (1) it is expensive, potentially costing thousands of dollars per patient per year, and (2) its efficacy as a treatment is not fully established.
Patient groups understandably are hoping for help of any kind for suffering patients.
Here is an opinion article advocating against approval by Jason Karlawish, M.D., Professor of Medicine, Medical Ethics and Health Policy, and Neurology at the University of Pennsylvania, and author of the book The Problem of Alzheimer’s.
Here is the Alzheimer’s Association’s October 23, 2020, submission in support of FDA approval of aducanumab.
