Since Alzheimer’s disease is so complicated, no single medicine or other treatment available currently will cure dementia. However, despite this, scientists have made significant progress in recent years in better understanding Alzheimer’s disease and creating and testing novel therapies, including numerous drugs currently in late-stage clinical studies.
The US Food and Drug Administration (FDA) has already authorized many prescription medications to help people living with Alzheimer’s disease manage their symptoms. For example, Aducanumab received expedited approval from the FDA on June 7, 2021. This medicine aims to reduce plaque buildup in the brain and may help halt Alzheimer’s disease progression. However, it still hasn’t been found to significantly affect clinical signs or results, such as cognitive decline or dementia progression.
Most drugs are generally effective in people with Alzheimer’s disease who have been in the early and mid-stages. It’s important to emphasize, however, that none of the currently available medications can reverse Alzheimer’s disease.
Apprehensions over Aduhelm’s FDA approval have prompted more research concerning its safety, efficacy, and cost. Consequently, certain insurance companies would not pay for it, and some organizations declined to prescribe it.
In this blog, let us learn more about this drug and its efficacy, eligibility, cost, and the surrounding controversy.
Aducanumab
Aducanumab is an amyloid-beta protein-targeting antibody treatment. People with Alzheimer’s disease have clusters of this protein in their brains.
These clusters, according to researchers, have a role in harming brain cells, leading them to cease functioning and die. This causes the symptoms we observe in persons with Alzheimer’s disease, such as dementia, to develop over time.
In 1991, the Alzheimer’s Society financed research that led to the identification of the first Alzheimer’s gene. Professor John Hardy’s research revealed the first conclusive proof of a buildup of amyloid plaques that may play a major role in the growth of Alzheimer’s disease and may even be the trigger for illness.
Alzheimer’s disease research has been greatly affected by the “amyloid hypothesis.” Aducanumab is one of almost 30 percent of current disease-modifying treatments in phase III studies that aims to prevent the illness by targeting amyloid.
How Does The New Drug Work?
The buildup of waste in the brain produced by the destruction of neurons, which leads to plaque development, is the hallmark of Alzheimer’s disease. Aduhelm is a monoclonal antibody that reduces the occurrence of amyloid-beta, a protein that causes plaques in the brain.
Aduhelm (aducanumab) is a drug that seeks to halt the decline of brain function and so change the disease progression.
There is no evidence that the memory-restoration process works. However, it has been proven to minimize the production of plaque.
Who is it For?
Based on the results of the clinical studies, the drug might be examined as a medication for individuals with early-stage Alzheimer’s disease. This term refers to Alzheimer’s patients who are in the early stages of the disease, such as mild dementia or moderate cognitive impairment.
People with Alzheimer’s disease who have been in the early stages of the condition may require support with tasks such as payment of bills, buying groceries, preparing food, or managing their money.
People who need help with clothing, showering, or even other essential duties are not considered at the onset of disease and should not use the drug.
Alzheimer’s disease has little effect on those who have mild cognitive impairment or dementia. There are a number of additional elements that have a role in these issues.
If you want to know if you have Alzheimer’s, ask your doctor about amyloid PET imaging or a lumbar puncture to ensure you have the plaques in the brain. A lumbar puncture is now covered by most insurance plans; regrettably, an amyloid PET scan (something that costs roughly $5,000) is still not.
1. Debatable Efficacy
The medicine was evaluated in people living with Alzheimer’s disease in their early stages before the illness significantly influenced their capacity to care for themselves. Therefore, it was not studied in adults with moderate dementia, a stage of dementia in which individuals require more assistance with daily tasks.
Despite a lack of proof, the FDA authorized the medicine under limited clinical settings. Biogen has been requested by the FDA to undertake a new experiment. It’s for patients who have a PET scan that shows they have beta-amyloid in their brain and are in the early stages of Alzheimer’s.
It’s a brand-new medicine that’s meant to halt the advancement of Alzheimer’s disease rather than cure it. Nonetheless, the findings of the trials remain inconclusive.
In 2019, Biogen halted the Phase III studies that led to aducanumab’s approval, citing a different data review committee’s conclusion that the medicine was unlikely to reach its endpoints. Despite the setback, the business submitted an application to the FDA the following year, claiming that large doses of aducanumab showed dramatically slow cognitive deterioration in certain patients.
2. Side Effects
In clinical studies, amyloid-related imaging abnormalities (ARIA) were the most common adverse effect of Aducanumab treatment. These are considered to be brain microbleeds or swelling and have been seen in prior anti-amyloid studies, particularly after high-dose administration.
According to Biogen, ARIA individuals had mild to severe symptoms, with some experiencing dizziness, headaches, and nausea. Due to these adverse effects, people who are taking Aducanumab will need to be monitored closely.
These adverse effects are more severe than those associated with other Alzheimer’s medications, although they are manageable. When people quit taking aducanumab, the symptoms go away, and in most cases, they can safely resume taking medicine later. However, individuals who are taking blood thinners or those who are otherwise at risk of bleeding should avoid using aducanumab.
3. Staggering Cost
Aside from questions regarding the effectiveness of aducanumab, Biogen has been criticized for the high cost of the new drug. Biogen has put a staggering $56,000-per-year cost on the medicine, even though price control regulator ICER estimated that a realistic cost for treatment with such scant evidence of benefit would lie between $2,500 and $8,300.
Even though the medication is covered by health insurance, users may be required to pay up to 20% in co-payments. Many individuals will not be able to afford it. There is much fear that this may worsen the already-existing racial and socioeconomic inequities in dementia care access.
I believe that the solution is for corporations to price these pharmaceuticals more cheaply and to provide effective patient-assistance initiatives so that no one is refused treatment because they cannot afford it.
4. Price Reduction
Biogen later cut the cost of its controversial new Alzheimer’s medicine Aduhelm, citing poor sales and rising criticism.
Later they dropped the price from $56,000 to $28,200 a year. During the same time, a group of Alzheimer’s specialists and health experts urged the Food and Drug Administration to withdraw the drug from the market and also said that they supported an effort to submit a legal petition with the administration.
5. Accelerated Approval
Aducanumab was authorized under the FDA’s Accelerated Approval Program, allowing medications that treat certain critical illnesses to be approved sooner. This enables patients to receive treatment sooner.
Aducanumab’s approval was predicated on the drug’s ability to decrease plaques in the brain. When following the fast approval process, pharma firms are obligated to undertake further studies to assess whether or not the medicine provides clinical benefit after it is approved.
Whereas, if a follow-up investigation fails to demonstrate medical efficacy, the FDA may remove the drug’s approval. The findings of phase 4 medical trials for aducanumab are anticipated in early 2030.
The Final Word
The FDA’s approval of Aducanumab has garnered mixed reactions. Some experts observed the decision as a watershed event for a discipline that hadn’t seen a new treatment in more than two decades. Others have called it a regulatory failure, including members of the FDA’s own advisory panel who resigned in protest.
Should you or a family member take aducanumab? You should first speak with your doctor before making this decision. Because we don’t know whether or not aducanumab works, opting to take it is akin to agreeing to take part in a research study.
The recognized adverse effects include 30% of persons experiencing temporary brain swelling and more than 10% experiencing minor brain bleeds. In addition, although it clears amyloid from the brain, experts don’t know if it slows the progression of dementia.
Experts are careful and optimistic about innovation in Alzheimer’s medicines that can slow or halt the disease’s progression. With a better knowledge of how Alzheimer’s affects the brain, possible Alzheimer’s therapies that short-circuit the disease mechanisms are being developed.
Therapies for Alzheimer’s disease in the future may contain a mix of pharmaceuticals, similar to how many malignancies and HIV/AIDS treatments comprise more than one medicine.
References
- https://magazine.ucsf.edu/can-controversial-new-drug-curb-alzheimers-disease
- https://www.health.harvard.edu/blog/a-new-alzheimers-drug-has-been-approved-but-should-you-take-it-202106082483
- https://www.pharmaceutical-technology.com/analysis/aducanumab-alzheimers-drug/
- https://www.ncoa.org/article/what-you-need-to-know-about-aduhelm
