BREAKING NEWS: Controversial Alzheimer’s Disease Drug Dumped

Biogen abandons clinical trials and halts production of aducanumab

The anti-amyloid monoclonal antibody drug aducanumab, trade named Aduhelm, will no longer be tested in people and its developer Biogen will no longer develop or test the drug, according to a January 31, 2024, article in MedPage Today.*

In 2021, Aduhelm was given “accelerated approval” by the Food and Drug Administration (FDA), but full approval was dependent on the outcome of the drug’s Phase III studies. While Medicare made the drug available at that time, it significantly limited coverage.

“A 2022 congressional investigation reported that the FDA broke with its own protocols in reviewing and approving aducanumab by inappropriately collaborating with Biogen on briefing documents, holding unreported meetings, and failing to gain internal consensus before engaging in these collaborations,” according to MedPage Today.

On March 31, 2023, MedPage Today reported that Aduhelm—along with other monoclonal antibody drugs created to diminish plaque formation in Alzheimer’s disease—actually caused patients’ brains to shrink, a hallmark of Alzheimer’s disease itself. See “BREAKING NEWS: Alzheimer’s Disease Drugs Make Patients' Brains Shrink,” from April 3, 2023.

*Judy George. “Controversial Alzheimer's Drug Abandoned—Biogen will stop developing and selling aducanumab.” MedPage Today, January 31, 2024.