Aducanumab Resources

In This Section

The US Food and Drug Administration (FDA) announced on June 7, 2021, the approval of aducanumab (Aduhelm). The drug was approved under the Accelerated Approval pathway, one of the alternative drug approval pathways.

The Academy provides resources to help its members understand the current landscape of the new Alzheimer’s disease drug, and how members can discuss it with patients.

Aducanumab (Aduhelm) Update

Biogen announced on January 31, 2024, they are discontinuing the production of aducanumab (Aduhelm). Clinical trial participants may continue in their studies through May 1, 2024 and patients with prescriptions can continue to receive treatments through November 1, 2024. Biogen has encouraged patients to contact treating physicians about next steps.

What the AAN Is Doing
The AAN formed a work group of experts in health policy, science, and education in July 2020 to prepare for a potential release of aducanumab and its implications for neurologists and their patients. While the AAN did not weigh in on whether the drug should be approved, we did submit comments in October 2020 for the FDA to consider around labeling.

Frequently Asked Questions

Recent News

What's Next for Patients Treated With Aducanumab? (Neurology Today®) |May 16, 2024

CMS Proposes Coverage with Evidence Development for Aducanumab What Does This Mean for Anti-Amyloid Therapies? (Neurology Today®) | April 7, 2022

AAN summary of final coverage determination for aducanumab | April 7, 2022

AAN provides public comments on proposed national coverage determination (NCD) | February 4, 2022

Mixed Response to the CMS Decision on Coverage for Aducanumab (Neurology Today®) | February 3, 2022

Navigating Aducanumab Decisions With Families: An AAN Position Statement (Neurology® podcast) | January 25, 2022

AAN summary of proposed coverage determination for aducanumab | January 12, 2022 

Cost-Effectiveness and Value-Based Pricing of Aducanumab for Patients With Early Alzheimer Disease (Neurology®) | January 12, 2022

 

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Advocacy and Payer Relations

AAN provides public comments on proposed national coverage determination (NCD) | February 4, 2022

AAN, Geriatrics, and Nuclear Medicine provide comments to CMS on coverage for aducanumab | November 22, 2021 

AAN provides comments to CMS on coverage for aducanumab | August 9, 2021

AAN, Geriatrics, and Nuclear Medicine request CMS cover beta amyloid PET | July 19, 2021

AAN provides public comment to ICER on aducanumab | July 15, 2021 

Capitol Hill Report: FDA Approves Aducanumab for Alzheimer’s Disease | June 7, 2021

AAN Comments to FDA Advisory Committee on Aducanumab Labeling | October 22, 2020

External Resources

CMS fact sheet for coverage for aducanumab | April 11, 2022

FDA revises aducanumab label to narrow the eligible patients | July 8, 2021 

"Dialogue: Current Perspectives on Aducanumab" Alzheimer's Association webinar | June 21, 2021

FDA Statement on Aducanumab Approval | June 7, 2021

FDA Label | June 7, 2021