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What is Aduhelm?

Aduhelm, brand name for aducanumab, was recently approved on June 7th, 2021 by the FDA for treatment of Alzheimer’s disease. FDA approved this drug for its ability to lower build-up of a protein in the brain, known as beta-amyloid. It is thought that lessening the amount of protein build-up will slow symptoms of Alzheimer’s disease, but this has yet to be proven.

Is this drug supposed to cure Alzheimer’s disease?

No, this drug in not intended to cure Alzheimer’s disease. It is the first new medication approved by the FDA for the treatment of Alzheimer’s disease after almost two decades. It is not expected to reverse or improve symptoms of the disease, but possibly slow down progression. 

Is this drug already available?

Aduhelm is not yet available and it is not known at this time when it will be on the market.

How is this drug taken?

Aduhelm is administered as an intravenous (IV) infusion over one hour every 4 weeks in a medical facility.

How effective is the drug in treating Alzheimer’s disease?

Many experts have questioned the approval from FDA for this agent based on the limited evidence of effectiveness. The FDA has granted a conditional approval based on Aduhelm’s ability to clear the toxic proteins beta-amyloid, which are associated with Alzheimer’s disease. However, there is limited evidence that this approach will slow down progression of the disease. As part of the conditional approval, the drug manufacturer, Biogen, is required to continue large clinical studies to show that removing the beta-amyloid plaque has actual benefits in improving memory and brain function.

Are there other reasons the drug approval has been so controversial?

There are several other reasons including the following:

  • Aduhelm failed to show any benefit in two large trials before the third trial which lead to the conditional FDA approval.
  • The medication has significant risk of common and serious side effects.
  • The FDA extended approval for use in all patients with Alzheimer’s disease when the research studies only included patients with mild memory and cognitive decline.
  • It is still not clear whether reduction in beta-amyloid protein impacts clinical status. In fact, many other investigational drugs which target beta amyloid protein have failed to show benefit and rightfully were not granted FDA approval.

What are the important common side effects?

Aduhelm can cause serious side effects including temporary swelling in the brain which may or may not cause headache, dizziness, confusion, nausea, and vision changes. Some patients may also have small spots of bleeding in or on the surface of the brain. There is also a risk of allergic reactions such as hives or itching, swelling of the face, lips, mouth, or tongue, flu-like symptoms, fever, shortness of breath and more. These can happen during and after the infusion with Aduhelm.

Will I need to have any blood work or imaging tests done to receive this drug?

You will be required to have a magnetic resonance imaging (MRI) done in the year before starting the infusions and again before the 7th dose and 12th dose. This is to monitor for some of the common side effects listed above.

Am I or my loved one a candidate for this drug?

When the drug becomes available, please visit your Neurologist for a complete consultation to discuss this agent and other treatment options.