Company Aims to Beat FDA Deadline by Nearly Four Years

Washington, D.C. (December 16, 2021) – The company that manufactures Aduhelm, the only treatment on the market that modifies the course of Alzheimer’s disease, announced plans to speed up follow-up trials in hopes of completing them in 2026. If successful, Biogen will beat the Food and Drug Administration’s (FDA) deadline by nearly four years. The company’s decision comes on the heels of UsAgainstAlzheimer’s applying pressure to speed up the process.

“This is tremendous news for Alzheimer’s patients and their families,” said George Vradenburg, chair and co-founder of UsAgainstAlzheimer’s. “Biogen clearly understands that Alzheimer’s patients don’t have time to wait. Ramping up trials and finishing the work in five years instead of nine is a clear indication that Biogen is listening to patients and taking action.”

Aduhelm is the only Alzheimer’s treatment that has been approved in the United States in nearly 20 years. The confirmatory study, which will include more than 1,300 early-stage Alzheimer’s patients, is a requirement by the FDA as part of its accelerated approval of the drug. The FDA, the federal agency ultimately responsible for determining a medication’s clinical benefit, concluded in June that Aduhelm was “reasonably likely to predict a clinical benefit to patients.” The confirmatory study to be conducted by Biogen will verify that Aduhelm is meeting the expected clinical benefit.

While the FDA gave Biogen until February 2030 to complete the study and submit a final report, Biogen now anticipates completing this process by spring of 2026.

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About UsAgainstAlzheimer’s

UsAgainstAlzheimer’s exists to conquer Alzheimer’s disease. We take on the toughest problems; bring all of “Us” together to break down barriers; advocate for research that will speed treatments to market; and drive changes that matter most to people living with the disease. We will not rest until brain-span equals lifespan - for everyone.