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Aduhelm Messaging

Aduhelm (generically known as aducanumab) is a monoclonal antibody that aims to remove amyloid from the brain. Amyloid is one of the substances that accumulates in excessive quantities in the brains of individuals with Alzheimer’s disease. Anti-amyloid drugs are being developed based on the hope that removing amyloid will result in symptomatic relief or slow progression of disease.

Rigorous clinical trials with Aduhelm showed that the drug did remove amyloid but without credible evidence of clinically meaningful benefit. The FDA nevertheless approved Aduhelm on June 7, 2021 for use in early stages of Alzheimer’s disease.

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Aduhelm pills in front of X Ray

Centers for Medicare & Medicaid Services Decision on Aduhelm - April 2022

On April 7, 2022, the Centers for Medicare & Medicaid Services (CMS) finalized its decision to limit its coverage of Aduhelm only to those individuals enrolled in randomized clinical trials conducted in a hospital-based outpatient setting. This decision was part of a broader national policy for coverage of any future FDA-approved monoclonal antibody directed against amyloid for use in Alzheimer’s disease.
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Aduhelm bottle

Centers for Medicare & Medicaid Services Decision on Aduhelm - January 2022

On January 11, 2022, the Centers for Medicare & Medicaid Services (CMS) decided to limit its coverage of Aduhelm only to those individuals enrolled in randomized clinical trials conducted in a hospital-based outpatient setting.
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Current Position of the Mesulam Center on Aduhelm-Aducanumab - August 2021

ADUHELM was approved by the FDA based on the manufacturer’s claim that it slows progression of Alzheimer’s disease by removing amyloid from the brain. The scientific evidence shows that ADUHELM does remove amyloid but there is no convincing proof yet that it has a clinical effect on symptoms or their progression. 
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FDA Approval of Aducanumab - June 2021

On June 7, 2021, the FDA approved aducanumab (trade name ADUHELM) for use in Alzheimer’s disease. This is a historic milestone. The last drug approval for Alzheimer’s disease happened 18 years ago. The FDA decision brings new hope to families with Alzheimer’s disease. However, this was a controversial decision.
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