Alzheimer’s disease is an incurable form of dementia that affects more than 6 million Americans. The disease causes memory loss and confusion that worsens as it progresses. On June 7th, 2021, the U.S. Food and Drug Administration (FDA) approved Aduhelm (aducanumab), a drug used to treat Alzheimer’s disease. The drug is manufactured by Biogen, a biotechnology company based in Massachusetts.

Aduhelm First Drug of Its Kind

Aduhelm is unlike any previous treatments for Alzheimer’s disease as it is the first drug that possibly alters the disease’s progression. According to the FDA, “Aduhelm is the first treatment directed at the underlying pathophysiology of Alzheimer’s disease, the presence of amyloid beta plaques in the brain. The clinical trials for Aduhelm were the first to show a reduction in these plaques.” Amyloid beta plaques in the brain are responsible for memory loss in Alzheimer’s patients, so the discovery of Aduhelm’s ability to reduce these plaques is groundbreaking.

Positron emission tomography (PET) imaging evaluates the number of amyloid beta plaques in the brain. These scans monitor the changes in the brain regions that Alzheimer’s disease affects the most. These scans will most likely be required for patients undergoing treatment with Aduhelm to monitor how their brain continues to react to taking the drug. PET imaging results from the 3,482 patients that participated in the three initial clinical trials are responsible for the FDA moving to approve Aduhelm.

First Alzheimer’s Drug Approval since 2003

It has been nearly 20 years since the last drug approval for Alzheimer’s disease in 2003. Approval of Aduhelm from the FDA was given using the accelerated approval pathway, which grants the drug approval before it has undergone all of the proper clinical trials. Aduhelm was given this special approval because the FDA believes this drug will provide extraordinary benefits to Alzheimer’s patients. Since the drug has not undergone all the necessary clinical trials, post-approval studies will be conducted to determine an accurate measure of the drug’s effectiveness. If the post-approval studies do not verify its effectiveness, the FDA could recall Aduhelm’s approval.

Costly New Milestone

While the approval of Aduhelm is a new milestone in the fight against Alzheimer’s disease, the drug comes with a hefty price tag. Biogen, the manufacturer, has priced a year’s supply of the drug at $56,000.00, making it highly unaffordable to many. The high cost poses health inequities among Alzheimer’s patients; lowering the price of Aduhelm would be beneficial in making the drug more accessible to all patients and improving their quality of life. Additionally, PET scans cost around $5000 per scan, which is an additional cost to the drug itself. It is unclear if the drug and scans will be covered by insurance programs, such as Medicare and Medicaid.

At Pulse ISM, we are very excited to see advancement in the treatment of Alzheimer’s disease. We are hopeful that Aduhelm will become more affordable and easier to access for all Alzheimer’s patients. Advanced medical imaging made evaluating the effectiveness of this drug possible, and Pulse ISM is proud to continue our work connecting medical imaging manufacturers with medical facilities and imaging departments. We are hopeful to see continual improvement in treatment and finding a way to #EndAlz.

References
Cavazzoni, P. (2021). FDA’s decision to approve new treatment for Alzheimer’s disease.
Retrieved from https://www.fda.gov/drugs/news-events-human-drugs/fdas-decision-approve-new-treatment-alzheimers-disease

O’Connor, M. (2021). Amyloid PET requirement is the latest controversy muddying historic
Alzheimer’s drug approval. Retrieved from https://www.healthimaging.com/topics/molecular/amyloid-pet-alzheimers-aducanumab-radiology-fda

U.S Drug and Food Administration. (2021, July 7) FDA grants accelerated approval for
Alzheimer’s drug. [Press release]. Retrieved from https://www.fda.gov/news-events/press-announcements/fda-grants-accelerated-approval-alzheimers-drug