FDA Approves Controversial New Alzheimer's Drug

Biogen's aducanumab receives green light, despite questions about effectiveness
By Newser Editors and Wire Services
Posted Jun 7, 2021 8:30 AM CDT
Updated Jun 7, 2021 10:30 AM CDT
FDA Approves Controversial New Alzheimer's Drug
In this 2018 file photo, Dr. William Burke goes over a PET brain scan at the Banner Alzheimer's Institute in Phoenix.   (AP Photo/Matt York, File)

Big news in the world of Alzheimer's: The FDA on Monday approved the first new treatment in nearly 20 years, disregarding warnings from independent advisers that the drug hasn't been shown to help slow the brain-destroying disease, per the AP. The drug aducanumab is made by Biogen and will be marketed as Aduhelm, per Axios. It's the only drug that US regulators have said can likely treat the underlying disease, rather than manage symptoms like anxiety and insomnia. The decision, which could impact millions of older Americans and their families, is certain to spark disagreements among physicians, medical researchers, and patient groups. It also has far-reaching implications for the standards used to evaluate experimental therapies, including those that show only incremental benefits.

The new drug, which Biogen developed with Japan's Eisai Co., didn't reverse mental decline, only slowing it in one study, per the New York Times. The drug is given as an infusion every four weeks. The FDA is requiring the drugmaker to conduct a follow-up study to confirm the drug's benefits for patients. If the study fails to show effectiveness, the FDA could pull the drug from the market, though the agency rarely does so. Biogen didn't immediately disclose the price, though analysts have estimated the drug could cost between $30,000 and $50,000 for a year's worth of treatment, per the Washington Post. Aducanumab (pronounced "add-yoo-CAN-yoo-mab") aims to help clear harmful clumps of a protein called beta-amyloid from the brain. Other experimental drugs have done that before but they made no difference in patients' ability to think, live independently, or take care of themselves. (More Alzheimer's disease stories.)

Get breaking news in your inbox.
What you need to know, as soon as we know it.
Sign up
Get the news faster.
Tap to install our app.
Install the Newser News app
in two easy steps:
1. Tap in your navigation bar.
2. Tap to Add to Home Screen.