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Alzheimer's Association Welcomes Revised Label for Aduhelm

Alzheimer's Association Welcomes Revised Label for Aduhelm
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July 8, 2021
Email: media@alz.org
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CHICAGO, July 8, 2021 — The Alzheimer’s Association is pleased with the announcement today that the Food and Drug Administration (FDA) has revised the prescribing label for Aduhelm™ (aducanumab). Consistent with the Alzheimer’s Association’s position, the updated label specifies the treatment should be initiated in patients in the disease stage studied in the clinical trials — people with mild cognitive impairment (MCI) or mild dementia stage of disease.

“Today’s announcement is consistent with the Alzheimer’s Association position that Aduhelm should be made available specifically to the population represented in the clinical trials where there was evidence of clinical benefit,” said Maria C. Carrillo, Ph.D., Alzheimer’s Association chief science officer. “We appreciate the FDA’s thoughtful consideration and response to the Alzheimer’s Association and others in the community including physicians, researchers and patients to ensure this treatment is prescribed only to those who may see benefit.”

The Alzheimer’s Association is committed to working with the Centers for Medicare & Medicaid Services (CMS) — and the private payer community — to expedite access for the appropriate population, which has such significant need.
 

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