Aducanumab (Aduhelm™) has been approved as a treatment for Alzheimer’s by the U.S. Food and Drug Administration (FDA). This is the first FDA-approved therapy to potentially delay decline from the disease, compared to current medications that only address symptoms.
It is also the first therapy to demonstrate that removing amyloid from the brain may delay decline in people living with Alzheimer’s. Approval of this therapy underscores the importance of early detection and diagnosis to ensure individuals receive the most benefit as soon as possible.
The historic approval of aducanumab ushers in an exciting era in Alzheimer’s and dementia treatment and research. Approvals of the first drug in a new category benefit people living with the disease by invigorating the field, increasing investments in treatents and generating innovation.
Is aducanumab a cure for Alzheimer’s and all other dementia?
Aduhelm — the branded drug from Biogen — is not a cure but is a very important advance for treatment. In clinical trials, it slowed the rate of cognitive and functional decline. This could mean more time for individuals to actively participate in daily life, have sustained independence and hold on to memories longer.
Aducanumab was studied in people living with early Alzheimer’s disease and mild cognitive impairment (MCI) due to Alzheimer’s who showed evidence of a buildup of amyloid plaques in the brain. The therapy has not yet been tested on people with more advanced cases of dementia.
Will this drug restore memories or cognitive function that has been lost?
There is no evidence that aducanumab can restore lost memories or cognitive function.
What is mild cognitive impairment?
Mild cognitive impairment (MCI) is an early stage of memory loss or other cognitive ability loss in individuals who maintain the ability to independently perform most activities of daily living.
How do I receive the Biogen treatment?
If you or a loved one is experiencing memory changes, the Alzheimer’s Association strongly encourages speaking with a health care provider for a thorough evaluation and diagnosis. Aducanumab may be a treatment option.
How is this drug administered?
Aducanumab is administered intravenously (IV) via a 45- to 60-minute infusion every 4 weeks. Infusion can be done at hospitals or infusion therapy centers, and can even be administered at a person’s home by specialized nurses.
When will it be available at my doctor?
Now that Aduhelm is approved, the manufacturer will need some time to ramp up large-scale production and arrange for nationwide — even global — distribution.
What are the side effects?
In clinical trials, the most common side effects were ARIA-E (abnormal brain changes associated with anti-amyloid treatments — most often swelling in the brain — that are spotted with neuroimaging techniques like MRI), headache, ARIA-H (micro hemorrhage/superficial siderosis) and fall.
Can I take this drug with my other medications/supplements?
When considering any treatment, including aducanumab, it is important to have a conversation with your health care provider to ensure you are a candidate for the treatment. This includes taking into account other health conditions, medications or supplements.
How will COVID-19 impact my ability to get this treatment?
Throughout the pandemic, our health care systems have adapted. People have continued to receive treatments, including infusions such as chemotherapy, with extra precautions such as social distancing and wearing a mask. Talk to your doctor to find out if aducanumab is right for you or a loved one, and discuss a plan to identify extra precautions for COVID safety.
It's a new day in the fight to end Alzheimer's
Approval of aducanumab is a milestone in the treatment of Alzheimer's. Current progress in science is significant, and we expect this will be the first of a number of treatments to come. Learn more.
ALZ Talks: New Advancements in Alzheimer’s Treatments
Join us on June 24 for a 30-minute webinar about aducanumab. Association experts will review what the drug is, how it is administered, what can be expected, who is eligible to receive it and steps for accessing the treatment.