The Food and Drug Administration (FDA) approved a new drug this month to treat Alzheimer’s disease. It is the first new treatment option since 2003. This move is exciting news for the millions of people living with this disease and the organizations dedicated to finding a cure. Biogen, the maker of this new drug called Aduhelm™ (aducanumab), is also excited about the FDA’s decision. However, some medical professionals are not too sure about this new treatment.
What is Alzheimer’s Disease?
Neurons with amyloid plaques (right side) – healthy neurons (left)
Alzheimer’s is a type of dementia, the name used to describe memory loss and the loss of other cognitive functions like thinking, dressing, and movement. As this disease progresses, 60 to 80 percent of people diagnosed with this brain disorder will, over time, lose their ability to care for themselves. In addition to the loss of precious memories, Alzheimer’s patients may not recognize their loved ones or remember who they themselves are. Unfortunately, there isn’t a cure, and it gets worse over time.
However, critics of the new treatment are not so sure. Researchers believe the disease occurs due to a build-up of amyloid protein pieces on the brain cell. These bits of amyloid are hard plaque-like deposits that surround the nerve cells or neurons in the brain of an Alzheimer’s patient. A healthy brain doesn’t allow the protein to build up and discards the invaders naturally. So even though this new drug, Aduhelm, is not a cure, Biogen believes it shows promise of slowing down Alzheimer’s disease progression.
The Reason Behind The Skepticism
This is not the first time the drug aduhelm was considered for treating Alzheimer’s disease. Biogen conducted two clinical trials under aduhelm’s scientific name aducanumab in 2017. Unfortunately, the drug’s effectiveness in one of those trials wasn’t enough to persuade an independent panel selected to monitor the trial’s outcome. This panel concluded that the drug’s performance would not meet the established requirements to deem it successful in treating mild to moderate Alzheimer’s.
The panel’s decision provoked Biogen to stop the first two trials, but they started a third phase III trial using a higher dose of aducanumab. The results of the third trial demonstrated that the higher dose did affect the amyloid proteins. This new dose reduced the cognitive functioning or behavior problems in a person with Alzheimer’s. Biogen presented these findings to the FDA and gained their accelerated approval despite the FDA’s own committee’s disapproval.
What’s The Next Step?
The FDA’s accelerated approval of the drug aduhelm does come with a requirement. Biogen must launch a “post-approval clinical trial” to prove the drug’s treatment for Alzheimer’s is beneficial. If the drug fails to work as prescribed, the FDA will cancel its approval and issue a recall.
In the meantime, participants in the study will receive the drug intravenously every four weeks. The study will treat patients with early-onset Alzheimer’s only with proof of amyloid in their brain. According to Biogen, the average cost per patient is estimated to be over $50,000 a year. This cost will vary for patients with insurance. The price may be costly initially, but the benefit for millions of Alzheimer’s patients and the health care industry is phenomenal.
Living with Alzheimer’s Until There Is A Cure
The FDA’s approval of Biogen’s drug, aduhelm, lets us know that researchers are working hard to find a cure for Alzheimer’s disease. But until then, people with this disease and their caregivers have options available to help with their daily living struggles. Organizations like the National Institutes on Aging, the Alzheimer’s Foundation, and the Alzheimer’s Association are just a few resources that offer a wealth of information to help you. In addition, these organizations can keep you up to date on the latest research and developments in finding a cure. They can also provide caregivers information about finding local support groups in their area and offer tips, strategies, and solutions to help get through each day.