FDA Changes Recommendations for Aduhelm™ (aducanumab)

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.

Just weeks after it approved the drug Aduhelm™ (aducanumab) for all Alzheimer's patients, the U.S. Food and Drug Administration (FDA) changed its recommendation. On July 8, 2021, the FDA announced a change in their original recommendations citing the drug should only be given to those with mild memory or thinking problems.

The original recommendation would have given roughly 6 million people in the U.S. a new drug for Alzheimer's disease. The new, more limited directions mean about 2 million people will be eligible for this treatment, according to The New York Times.1

Concerns around side effects

Many doctors disagreed with the FDA’s approval of the drug for all people with Alzheimer's. Among the concerns was the fact that Aduhelm can cause brain swelling and brain bleeding, which may make the drug more dangerous for people with certain medical conditions. Also, people with diabetes, high blood pressure, and those taking blood thinners did not participate in any of Aduhelm’s clinical trials. This means doctors do not know how people with these common health issues can take the drug safely.1

The company that makes Aduhelm, Biogen, said that the FDA's approval had been narrowed to include only the type of people who participated in the drug's clinical trials. Only people with mild cognitive issues or mild dementia caused by Alzheimer’s were studied.2

About Aduhelm

Aduhelm is the first drug of its kind to be approved for Alzheimer's. It is being sold in the United States under the FDA's accelerated approval program. Continued approval is dependent on verifying the drug's benefits and side effects in more clinical trials.2-4

What are the ingredients in Aduhelm?

The active ingredient in Aduhelm is aducanumab.3

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:5

  • 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.3

What are the possible side effects of Aduhelm?

The side effects of Aduhelm may include:3

  • 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.

Read more about Aduhelm.

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