Editor's note: the Aduhelm (aducanumab) drug recommendations have changed since its original FDA approval in June 2021. You can see all updates regarding Biogen's Aduhelm here.
Aduhelm™ (aducanumab) is a first-of-its-kind drug approved for Alzheimer’s disease. This is exciting news for the Alzheimer’s community, as it is the first new drug approved for Alzheimer’s in 18 years. In June 2021, the U.S. Food and Drug Administration (FDA) gave accelerated approval for Aduhelm as the first therapy that targets the changes in the brain that cause Alzheimer’s.1-3
The FDA may give accelerated approval to new drugs that treat a health condition with few or no other treatments. This means drugs like Aduhelm can be sold sooner. Continued approval is dependent on verifying the drug’s benefits and side effects in clinical trials.1-3
Nearly 3,500 people with Alzheimer’s were represented in 3 separate studies. The studies included studies that were randomized, placebo-controlled, and dose-ranging. Those receiving Aduhelm had significant decreases in beta-amyloid plaque, while those who received a placebo had no decrease in plaque. However, even with the decrease in beta-amyloid plaques, several studies have given mixed results when it comes to whether this can slow down Alzheimer’s disease progression. 1
What are the ingredients in Aduhelm™?
The active ingredient in Aduhelm is aducanumab.2
How does Aduhelm work?
In Alzheimer’s disease, plaques in the brain form when protein pieces called beta-amyloid clump together. These clumps of beta-amyloid are sticky and form plaques in the brain. The plaques block nerve signals within the brain, activate the immune system, and trigger brain inflammation. A buildup of these plaques can be associated with the classic symptoms of Alzheimer’s, including problems with:4
- Learning and memory
- Thinking and planning
- Speaking and understanding speech
- Sensing where your body is in relation to objects around you
Aduhelm is a laboratory-made antibody that reduces the beta-amyloid plaques in the brains of those with Alzheimer’s disease.2
What are the possible side effects of Aduhelm?
The side effects of Aduhelm may include:2
- Amyloid Related Imaging Abnormalities (ARIA). ARIA most commonly is temporary swelling in areas of the brain that resolves over time.
- Hypersensitivity (allergic) reactions
- Headache
- Fall
- Diarrhea
- Confusion
- Delirium
- Altered mental status
- Disorientation
- Immunogenicity, an unwanted immune response
These are not all the possible side effects of Aduhelm. Talk to your doctor about what to expect or if you experience any changes that concern you during treatment with Aduhelm.
Things to know about Aduhelm
Amyloid-related imaging abnormalities (ARIA) most often present as temporary swelling in different areas of the brain. The swelling usually resolves over time. Some people may also have small spots of bleeding in or on the surface of the brain. Most people with swelling do not have symptoms. However, some people may have symptoms such as headache, confusion, dizziness, vision changes, or nausea.2
Aduhelm is given by iv injection (through the vein) over the course of 1 hour. After the second infusion, your doctor might change the dose. Talk to your doctor if you have questions about the dosing of this drug.2
Right now, it is not clear what requirements insurance companies will place on Aduhelm before providing coverage for this therapy. It is likely that a magnetic resonance image (MRI) of the brain will be mandatory to make sure that there is not a high risk of bleeding. A high risk of bleeding may prevent Aduhelm from being prescribed. Another scan called an Amyloid PET scan may also be required to make sure that the memory loss is caused by Alzheimer’s disease and not something else. These details are still being worked out, so your doctor may not know yet which patients should or can try Aduhelm.
If you miss an infusion of Aduhelm, resume the same dose as soon as possible. Infusions are to be given every 4 weeks and at least 21 days apart.2
It is not known if Aduhelm can harm an unborn baby. If you or your partner can become pregnant, you should use birth control during treatment and for some time after the last dose of Aduhelm. You should also not breastfeed during treatment with Aduhelm and for some time after the last dose. Talk to your doctor about your options for birth control and breastfeeding while taking Aduhelm.2
Per package insert, there is no data on the presence of aducanumab-avwa in human milk, the effects on the breastfed infant, or the effects of the drug on milk production.
Talk to your doctor
Before beginning treatment for Alzheimer’s disease, tell your doctor about all your health conditions and any other drugs, vitamins, or supplements you are taking. This includes over-the-counter drugs.2
For more information, read the full prescribing information for Aduhelm.2
