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On June 7 of this year, the U.S. Food & Drug Administration (FDA) approved the first novel therapy for Alzheimer’s disease in nearly two decades. With over 6 million Americans currently living with the disease, the approval certainly made history.
Alzheimer’s today
As a disease that decelerates memory and cognitive function over time, Alzheimer’s — a devastating form of dementia — has become the sixth leading cause of death in the United States. And with the disease primarily effecting older adults, including roughly 42% of assisted living residents in the U.S., the topic of treatment has long been relevant in the senior living industry.
“The need for treatment is urgent,” said Patrizia Cavazzoni, M.D., director of the FDA Center for Drug Evaluation and Research.
FDA approves novel therapy
What exactly is the latest treatment for Alzheimer’s, and what does the approval mean? As the decision generated significant attention, the FDA announcement aimed to answer such questions. Let’s take a look:
The therapy, Aduhelm (aducanumab), has been authorized to treat patients with Alzheimer’s disease using the accelerated approval pathway. Under this, the FDA approves a drug for a serious or life-threatening illness — if it may provide meaningful therapeutic benefit over existing treatments.
While the treatment doesn’t cure or reverse Alzheimer’s disease, the FDA announcement emphasized that “the approval is significant in many ways.” To name a few:
- Aduhelm is the first novel therapy approved for Alzheimer’s since 2003
- It’s the first treatment directed at the underlying pathophysiology of the disease, which is the presence of amyloid beta plaques in the brain
- The clinical trials were the first to show that a reduction in plaques is expected to reduce the clinical decline of Alzheimer’s
For some, these findings were seen as a positive breakthrough. For others, the approval sparked controversy and intense debate given the uncertainties of Aduhelm and its effect on Alzheimer’s patients.
“The data included in the applicant’s submission were highly complex and left residual uncertainties regarding clinical benefit,” shared the FDA in their announcement. “There has been considerable public debate on whether Aduhelm should be approved. As is often the case when it comes to interpreting scientific data, the expert community has offered differing perspectives.”
So, what are the uncertainties?
Relayed by McKnight’s Senior Living, Aduhelm underwent two “phase three” clinical trials. One showed a reduction in clinical decline for Alzheimer’s patients, whereas the second trial did not. However, both trials indicated that the treatment reduced plaque levels in the brain.
And according to the FDA, this reduction is expected to reduce clinical decline in those with Alzheimer’s. With that, they moved forward with the approval — concluding that the benefits outweighed the risks. Next steps involve a phase four confirmatory trial in which the clinical benefit is verified. If it can’t be verified, the FDA could remove Aduhelm from the market.
The approval ultimately led to mixed responses from researchers, advisors and medical experts. Nonetheless, the treatment has potential to change the lives of those with Alzheimer’s and their families, including older adults residing in senior living communities. Read more about the approved Alzheimer’s treatment and the implications.
