What You Need To Know About Aducanumab
The recent FDA approval of aducanumab for the treatment of Alzheimers disease has left people with a lot of questions. As the first drug authorized to treat Alzheimers since 2003, it has given hope to people who have had few treatment options for this devastating disease. However, aducanumab is not a cure for Alzheimers disease and it is not for all people with memory loss or Alzheimers disease. Here, Duke geriatric psychiatrist Kim Johnson, MD, answers some frequently asked questions about the new drug and how to find out if it might be an option for you.
Q: Many Doctors Say They Wont Prescribe Aducanumab And At Least Two Respected Medical Centers The Cleveland Clinic And The Mount Sinai Health System Have Said They Will Not Give It To Patients Until More Data Are Available
A: I dont agree with that approach. I think there is enough evidence to suggest that if you treat the right people with this drug, they are likely to benefit. I agree that this is not a home-run drug, I agree that the data could be clearer, and I can understand physicians who are worried and reluctant. That being said, Im not ready to throw the drug out entirely now that the FDA has approved it.
Alzheimers disease is a devastating illness. Given the choice between the certainty of decline and the chance that a drug like this might slow that process even if the benefit is modest, and there is risk involved many patients will choose to take that risk. I feel we have an obligation to discuss this drug as an option for our patients who might benefit.
Q: How Does Aducanumab Treat Alzheimers Disease
A: Alzheimers disease is defined by two protein deposits that are found in the brain: amyloid plaques and tau tangles. Aducanumab targets the plaques. Its whats called a monoclonal antibody, which works like the antibodies made by your immune system: It attacks amyloid plaques as if they were a virus or other foreign entity.
Aducanumab is the first Alzheimers drug that is very effective at clearing these plaques. This was shown in a phase I clinical trial, where youre just testing to see if the drug is safe. When researchers looked at brain scans called amyloid PET scans that can image the plaques, they saw this remarkable phenomenon: The plaques were disappearing. That created a lot of excitement in the field. It led the manufacturer, Biogen, to jump right into phase III trials, which were designed to test whether the drug slowed cognitive decline for patients with amyloid plaques who were in early stages of memory loss.
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How Much Does Treatment Cost
Aducanumab comes with a hefty price tag.
Biogen said Monday the wholesale cost of treatment with aducanumab which requires an infusion once every four weeks is about $4,312 per infusion, making the annual cost around $56,000 for a high dose.
The company also noted that for qualified, commercially insured patients, their out-of-pocket costs could be reduced to as low as $0 under certain assistance programs. Patients covered by Medicare through a Medicare Advantage plan have a maximum annual out-of-pocket cap. Biogen mentioned working on initiatives with Cigna, the Veterans Health Administration, CVS Health and the National Association of Free and Charitable Clinics.
Still, it is unclear at this point as Medicare and insurance companies will determine whether the cost of medications will be covered, Marylands Biernot said. The current estimated cost can certainly be a barrier which affects equitable access to this medication.
For the next four years, Biogen plans not to increase the price of aducanumab.
We have voluntarily committed to not taking any price increase over the next four years. Thats a really important commitment were making, and were also remaining open minded, Chirfi Guindo, Biogens head of global product strategy and commercialization, said during an investors call on Tuesday morning.
What Are The Drugs Side Effects
Mainly swelling or bleeding in the brain. This sounds really scary, but the swelling is reversible, and the bleeds are tiny what we call microbleeds. In the trials, fewer than 1% of people treated with aducanumab had what we would consider very severe symptoms, including seizures or stroke-like episodes. Most participants who experienced swelling or bleeding had no symptoms or only mild ones, like dizziness or a little more confusion.
These side effects are more serious than with other Alzheimers drugs, but they can be managed. They resolve when patients stop taking aducanumab, and in most instances, patients can safely restart the drug later. However, people who are on blood thinners or who otherwise might be prone to bleeding should avoid taking aducanumab altogether.
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Accelerated Approval By The Fda
The FDA announced that it gave accelerated approval to Aduhelm because it expects that the drugs well-demonstrated ability to reduce levels of aggregated amyloid in the brain will yield cognitive clinical benefit to patients. Because Aduhelms phase 3 clinical trials did not achieve these benefits for participants under their original design, the drug did not meet the FDAs usual standards for unconditional approval.
The accelerated approval program is designed to allow drugs to reach the market quickly that have demonstrated that they affect a surrogate biomarker in a way that scientific evidence strongly suggests will lead to clinical benefit to patients, even if the benefit was not achieved during the course of the trials. As an example, in cancer, tumor size reduction may be a surrogate biomarker for improving a cancer patients prognosis. Under accelerated approval, a drugs sponsor, like Biogen for Aducanumab, must run a confirmatory post-approval study demonstrating that patients benefit cognitively from the drug or the FDA can act to remove it from the market. The FDA gave Biogen until 2030 to complete this trial Biogen has announced its intention to act faster but has not provided a timeline.
Are You Concerned About The Cost
Biogen has set the wholesale price for aducanumab at $56,000 a year. Thats way too high. Even if the drug is covered by Medicare, patients might still be liable for up to 20% in copays. A lot of people wont be able to afford that. There is huge concern that this will exacerbate the racial and socioeconomic disparities that already exist in access to dementia care. I think the solution is for companies to price these drugs more reasonably and offer robust patient-assistance programs so no one is denied treatment because they cant afford it.
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The Researchers Have Claimed That Lecanemab The Drug That Selectively Binds And Neutralises Toxic Beta Amyloid Aggregates Proves The Amyloid Hypothesis This Theory Posits That Abnormal Accumulation Of The Beta Amyloid In The Brain Is One Of The Main Causes Of Alzheimers Disease
An under-investigation drug has resulted in reduced cognitive decline in patients with early Alzheimers, promising to become one of the first neuro-protective therapies for the disease. The companies, Eisai and Biogen, recently announced the results of a phase III trial conducted with 1,795 participants, who already had plaques of the protein called amyloid in their brains.
The yet-to-be peer-reviewed report showed that there was 27 per cent less decline in the cognitive function of people who took the medicine Lecanemab as compared to those who did not after 18 months. The cognitive decline of the study participants was measured on the DR-SB: Clinical Dementia Rating-Sum of Boxes scale that assesses performances of the patient in six areas memory, orientation, judgment and problem solving, community affairs, home and hobbies, and personal care.
Why are the findings significant?
This is probably the very first drug that has claimed to slow the progression of the disease. At present, the treatment for Alzheimers is mainly symptomatic. There are a few pills that improve memory in early stages but they do not help in the other facets of Alzheimers. There is certainly a need for such neuro-protective drugs for dementia and there are several drugs in the pipeline, said Dr Rajendra Dhamija, a neurologist and director of the Institute of Human Behaviour and Allied Sciences .
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As pioneers in neuroscience, we believe defeating this disease will require multiple approaches and treatment options, and we look forward to continuing the discussion about the significance of these findings with the patient, scientific, and medical communities, he said.
News of the milestone study, known as Clarity AD, also rippled in the finance world Biogens stock soared around $73 to $270 upon the major announcement, Yahoo! Finance reported.
We think that lecanemab holds mega blockbuster potential, likely in the $6 to $8 billion range, Guggenheim Partners analyst Yatin Suneja wrote in a client memo on Wednesday.
Lecanemab represents a major rebound for Biogen after Aduhelm the companys previous try at an Alzheimers treatment failed when brought to market in 2021, the New York Times reported.
The new drugs intended, neurological purpose is to clear away plaques formed on the brain by an Alzheimers-connected protein called amyloid, thus reducing the diseases major effects.
Eisai representatives will present the Clarity AD study findings to the Clinical Trials on Alzheimers Congress in late November and will publish the research to a peer-reviewed medical journal.
Eisai believes these findings will create new horizons in the diagnosis and treatment of Alzheimers disease as well as further activate innovation for new treatment options, company CEO Haruo Naito said.
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The FDA also said the data supporting its approval was “highly complex” and left “residual uncertainties.” about its benefit.
The FDA will require Biogen to conduct a new, large clinical trial to determine the drug’s benefit, and reserves the right to rescind the approval in the future. Meanwhile, patients will have access to the drug, which is given by intravenous infusion.
“At the end of the day, we followed our usual course of action when making regulatory decisions in situations where the data are not straightforward,” the FDA wrote.
Although controversial, Aduhelm’s approval is significant because it is the first drug to slow down disease progression. For millions of patients, Aduhelm is a promising new treatment option to manage a debilitating disease for which there are few existing options.
“This is the first time the FDA has conditionally approved a drug for the early treatment of Alzheimers in 20 years,” said Dr. Jennifer Ashston, ABC Chief Medical Correspondent. “This is something that is potentially encouraging news for the 1 in 9 Americans over the age of 65 who are facing a diagnosis of Alzheimers.”
“The trials give us hope,” says Ron DeChant, a retired pharmacist and patient with Alzheimer’s disease. “I entered the study in 2016 knowing the risks involved but was encouraged that we were doing all we could to learn about Alzheimer’s disease.”
Others involved in the clinical trials also agree real-world implementation will be complex.
How Soon Could Someone Who Meets The Criteria To Receive Aducanumab Start Treatment
That date is still an unknown. We dont know when the drug will be on the market, although Biogen says soon. We also need the right space to properly administer the infusions for these patients. Furthermore, it is unclear how health insurance companies will cover the treatment. Its estimated the medication will cost $56,000 per year for each patient with significant additional cost associated with the infusion delivery, clinical monitoring and imaging. We need to understand the cost so that we can be transparent with people because there is no benefit for you to go on this treatment for six months and quit. That will only thing expose you to the potential risks. This drug is a long term commitment the therapeutic benefits arise well down the road.
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New Alzheimers Drug Is 1st Of Its Kind To Be Fda Approved
It’s the first drug proven to slow the progression of Alzheimers disease.
In a major development for patients and the biotechnology industry, the U.S. Food and Drug Administration approved the use of a new drug, Aduhelm , for treating early Alzheimer’s disease.
“This is the first time we have any new approved treatment for Alzheimer’s disease over the past two decades,” said Dr. Babak Tousi, who led Cleveland Clinic’s study site for the multicenter clinical trials.
But the new drug, made by the biotechnology company Biogen, has been marred by controversy throughout its development history, with prominent Alzheimer’s disease specialists arguing the drug’s benefits are unlikely to outweigh the risk of serious side effects.
In a statement announcing the approval, the FDA acknowledged the controversy surrounding and “differing perspectives” surrounding Aduhelm.
Success Of Experimental Alzheimers Drug Hailed As Historic Moment
Study shows cognition in early-stage patients on lecanemab declines by 27% less than those on placebo
An experimental drug has slowed the rate of decline in memory and thinking in people with early Alzheimers disease in what is being described as a historic moment for dementia treatment.
The cognition of Alzheimers patients given the drug, developed by Eisai and Biogen, declined by 27% less than those on a placebo treatment after 18 months. This is a modest change in clinical outcome but it is the first time any drug has been clearly shown to alter the diseases trajectory.
This is a historic moment for dementia research, as this is the first phase 3 trial of an Alzheimers drug in a generation to successfully slow cognitive decline, said Dr Susan Kohlhaas, the director of research at Alzheimers Research UK. Many people feel Alzheimers is an inevitable part of ageing. This spells it out: if you intervene early you can make an impact on how people progress.
In the study, which enrolled roughly 1,800 patients with early stage Alzheimers, patients were given twice-weekly infusions of the drug, called lecanemab. It was also shown to reduce toxic plaques in the brain and slow patients memory decline and ability to perform day-to-day tasks.
About a fifth of patients experienced side-effects, including brain swelling or brain bleeding visible on PET scans, with about 3% of those patients experiencing symptomatic side-effects.
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Can This Controversial New Drug Curb Alzheimers Disease
In June, when the U.S. Food and Drug Administration approved the drug aducanumab for treating Alzheimers disease, reactions were mixed. For some experts, the decision marked a breakthrough moment for a field that hasnt offered a new therapy in more than 20 years. Others including three members of the FDAs own advisory committee, who resigned in protest called it a regulatory failure.
UCSF neurologist Gil Rabinovici, M.D., explains the controversy and shares why he thinks Alzheimers care is entering a new era regardless of whether aducanumab proves to be a blockbuster or a bust.
Q: How Did The Drug Become So Controversial
A: In February 2019, Biogen suddenly announced that they had stopped the phase III trials. Basically, their statisticians had determined, based on the results so far, that there was a very low likelihood that the drug would show a difference in clinical outcomes compared with a placebo. Then, eight months later, the company made another sudden announcement: As more of the trial data had become available, they had found that one of the trials in which more people received the highest dose of the drug actually was successful.
In the following months, Biogen worked closely with the FDA to try to understand these very complicated data. There are now allegations that this relationship was a little too close. At least two congressional committees and the Office of the Inspector General are investigating. Its still to be determined whether anything inappropriate happened or not.
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Not Giving Up On Amyloid
While research outside amyloid is accelerating, former Food and Drug Administration scientist, Dr. Yaning Wang, now the CEO of a clinical-stage biotech firm, is urging scientists to not wholly abandon the development of amyloid-fighting drugs.
Likewise, Dennis Selkoe, a neurologist at Harvard Medical School and Brigham and Womens Hospital, is also pushing for the continued development of drugs that target amyloid.
He co-authored a paper published in the journal PLOS Biology last month that noted that amyloid is still likely one of several factors that play a role in the development of the disease and that clinical trials targeting the plaque have been fraught with missteps.
Both Wang and Selkoe said scientists are eagerly awaiting data from another amyloid-targeting drug, from Biogen and Eisai, expected in the fall.
At the same time, Selkoe is calling for more research into treatments that target tangled tau proteins, also commonly found in Alzheimers patients, and the activation of microglia, the immune cells of the central nervous system that play a role in brain inflammation.
Tau and microglia appear to be important additional factors, but they appear to be precipitated by amyloid accumulation, he said.
He said its only a matter of time before we see more research discoveries that show potential for slowing Alzheimers disease, possibly within the next year or two.
Value And Costs To Patients And The Health Care System
The value to a patient and their loved ones of more time with more independence is vitally important yet incalculable. For patients in the early stages of AD like those in the Aduhelm clinical trials, slowing the loss of cognitive function could mean being able to work, drive, and/or manage their life themselves for a few extra months, delaying some of the need for paid and unpaid caregiving. Experts are divided on whether the 22% slower rate of decline seen in the one positive Aduhelm study would be noticeable to patients and families, and there is no evidence yet regarding whether taking Aduhelm for longer than the trial period might increase its benefits. People with Alzheimers also progress in their disease at different rates, further complicating the analysis. The intangible value and financial savings from the possible delay in decline are very challenging to estimate and will differ from person to person.
Approximately six million people in the United States have an Alzheimers diagnosis that would make them eligible for Aduhelm under the label originally approved by the FDA to guide doctors in determining patient eligibility. The estimate of the eligible patient population under the revised label is approximately one to two million. Most researchers expect that many more people have mild memory concerns and would be amyloid positive if tested but have not yet sought or received a diagnosis.
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