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.
The Alzheimer's Association leads the way to end Alzheimer's and all other dementia — by accelerating global research, driving risk reduction and early detection, and maximizing quality care and support. Our vision is a world without Alzheimer's and all other dementia®. For more information, visit www.alz.org or call the 24/7 Helpline at 800.272.3900.