Aducanumab

What is aducanumab?

  • Aducanumab is a proposed treatment for early Alzheimer’s disease that is intended to slow the progression of the disease.
  • Aducanumab does this by targeting collections of toxic protein in the brain (amyloid beta plaques) hoping to reduce that buildup, a hallmark of Alzheimer’s disease.
  • Unlike other Alzheimer’s drugs which attempt to ease symptoms of the disease, Aducanumab is designed to slow the rate of cognitive and functional decline in persons in the earlier stages of Alzheimer’s and may help preserve the cognitive abilities and functions of these patients for a longer time.
  • Aducanumab, which has been developed by Biogen, is currently being reviewed by the Food and Drug Administration, with a decision expected by the first quarter of 2021.
  • If approved, aducanumab would be the first disease-modifying therapy approved for use in the U.S.
  • Aducanumab was studied in people living with early-stage Alzheimer’s disease; it has not been studied in individuals with moderate to severe Alzheimer’s.

What it can mean for the future of Alzheimer’s disease  treatment?

  • Approving this drug will offer hope, catalyze advanced blood tests and encourage diagnosis of the disease earlier and more effectively.
  • This would be the first approved therapy for the treatment of Alzheimer’s disease in over 17 years. No other disease on the scale of Alzheimer’s has gone as long without therapeutic relief.
  • Aducanumab delivers real improvements in patients’ quality of life. This therapy significantly slowed decline in six critical clinical aspects of Alzheimer’s patients’ lives, including cognition and functional independence.
  • Aducanumab offers real clinical benefit to millions of Alzheimer’s patients who currently are devoid of a meaningful therapy.

Aducanumab and the Global Alzheimer’s Platform Foundation

  • The Global Alzheimer’s Platform Foundation (GAP) is dedicated to speeding the delivery of innovative therapies to those living with Alzheimer’s by reducing the time and cost of Alzheimer’s disease (AD) clinical trials. The results of the aducanumab study are directly related to those who participated in Biogen’s clinical trial. Without their involvement there would have been no study at all.
  • When the aducanumab clinical trial abruptly ended last year after early results showed that it was ineffective, the participants of the study were devastated and their families heartbroken. When Biogen reexamined the results and found that aducanumab could help slow the progression of Alzheimer’s for patients in the early stages of the disease, their families were given hope one again.
  • With over 20% of the novel coronavirus (COVID-19) related deaths happening in nursing homes, keeping Alzheimer’s patients out of long term care facilities and with their families is crucial. Aducanumab would allow for those taking it to keep their cognitive and functional abilities for longer, delaying the option of nursing homes or other long term care facilities.
  • GAP believes not only will the approval of aducanumab help those living with Alzheimer’s right now, but it will spark pharmaceutical innovation and investment in disease-modifying treatments and therapies, and get more people involved in AD clinical trials. 

What needs to happen?

  • The FDA needs to clearly define “clinically meaningful” benefits, which is used to determine if an Alzheimer’s drug is proven to show improvement in a patient’s cognition, memory and day-to-day function.
  • Biogen needs to continue the clinical trial to further prove the efficacy and safety of aducanumab. The FDA’s hesitancy comes from an independent panel’s concern of only one clinical trial showing promising results, while the other showed no improvement.

How can you help?

Reach out to the U.S Food and Drug Administration with the following message:

I urge the U.S. Food and Drug Administration to approve aducanumab. By delaying the progression for people in the early stages of the disease, this drug therapy will give people more time to live independently and perform daily activities longer.

Statement by George Vradenburg, Board chairman of the Global Alzheimer’s Platform Foundation and UsAgainstAlzheimer’s chairman and co-founder

Statement by John Dwyer, president and founding board member of the Global Alzheimer’s Platform Foundation and UsAgainstAlzheimer’s founding board member