‘this Drug Is Not For Everyone’
The FDA’s accelerated approval of lecanemab was expected, said Dr. Richard Isaacson, director of the Alzheimer’s Prevention Clinic in the Center for Brain Health at Florida Atlantic University’s Schmidt College of Medicine.
Isaacson said lecanemab can be “another tool” in his toolbox to fight Alzheimer’s disease.
“I will prescribe this drug in the right person, at the right dose and in a very carefully monitored way, but this drug is not for everyone,” he said.
“I would do genetic testing for APOE4 first. I would have a frank discussion with my patients,” he said. “If someone is having side effects, if someone is on a blood-thinning medication, if someone has a problem, they need to discuss this with the treating physician, and they need to seek medical attention immediately.”
Alzheimer’s Association Statement: Alzheimer’s Association Welcomes Us Fda Approval Of Lecanemab
Association Renews Urgent Call for CMS to Cover FDA-Approved Alzheimer’s Treatments
CHICAGO, Jan. 6, 2023 /PRNewswire/ — The Alzheimer’s Association enthusiastically welcomes today’s U.S. Food and Drug Administration action to grant the accelerated approval of Leqembi for the treatment of patients in mild cognitive impairment or mild dementia stage of Alzheimer’s disease and with confirmation of amyloid beta. While this is a milestone achievement for people eligible for the treatment, their families and the research community, without Centers for Medicare & Medicaid Services and insurance coverage of this treatment and others in its class, access for those who could benefit from the newly-approved treatment will only be available to those who can pay out-of-pocket.
“The unquestionably positive data from the clinical studies of Leqembi indicate that thorough removal of beta amyloid from the brain leads to clinical benefit,” said , Ph.D., Alzheimer’s Association chief science officer. “This treatment can change the course of Alzheimer’s in a meaningful way for people in the early stages of the disease, allowing more time to participate in daily life and live independently.”
“The decision to use this treatment should lie in the hands of the individual living with the disease and their family, in consultation with their doctor,” Carrillo added.
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Will Medicare Cover It
Lecanemab will carry a wholesale price of $26,500 per patient per year, the drugs manufacturers announced Friday.
Biogen and Eisai have listed the drug slightly below the reduced price of the Alzheimers medication Aduhelm, which now costs an average patient about $28,200. The companies had to lower the cost of Aduhelm originally set at $56,000 per patient per year after insurers balked at covering it.
In justifying the cost of Leqembi, the companies said in a news release that based on the estimated quality of life gained by people who take it, the value of the medication to society is around $37,000 a year, but they chose to go lower aiming to promote broader patient access, reduce overall financial burden, and support health system sustainability.
The wholesale cost of a drug is akin to a cars sticker price. It isnt necessarily what patients will pay after insurance or other discounts are factored in.
Insurance coverage for this medication is not a given, however. Medicare restricted its coverage of lecanemabs sister drug, Aduhelm, after clinical trials showed questionable benefits to patients. The agency agreed to cover the drug only for people enrolled in registered clinical trials, which limited access to the medication.
What Is Known About Lecanemab
Lecanemab, a monoclonal antibody, is not a cure but works by binding to amyloid beta, a hallmark of Alzheimers disease. In late November, results from an 18-month Phase 3 clinical trial published in The New England Journal of Medicine showed that lecanemab reduced markers of amyloid in early Alzheimers disease and resulted in moderately less decline on measures of cognition and function than placebo at 18 months but was associated with adverse events.
The results also showed that about 6.9% of the trial participants given lecanemab, as an intravenous infusion, discontinued the trial due to adverse events, compared with 2.9% of those given a placebo. Overall, there were serious adverse events in 14% of the lecanemab group and 11.3% of the placebo group.
The most common adverse events in the lecanemab group were reactions to the intravenous infusions and abnormalities on their MRIs, such as brain swelling and bleeding called amyloid-related imaging abnormalities, or ARIA, which can become life-threatening.
Some people who get ARIA may not have symptoms, but it can occasionally lead to hospitalization or lasting impairment. And the frequency of ARIA appeared to be higher in people who had a gene called APOE4, which can raise the risk of Alzheimers disease or other dementias. ARIA were numerically less common among APOE4 noncarriers, the study showed.
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Alzheimer’s Drug Lecanemab Receives Accelerated Approval Amid Safety Concerns
The US Food and Drug Administration granted accelerated approval on January 6 for the Alzheimer’s disease drug Lecanemab, one of the first experimental dementia drugs to appear to slow the progression of cognitive decline.
— The US Food and Drug Administration granted accelerated approval Friday for the Alzheimer’s disease drug lecanemab, one of the first experimental dementia drugs to appear to slow the progression of cognitive decline.
“Alzheimer’s disease immeasurably incapacitates the lives of those who suffer from it and has devastating effects on their loved ones,” Dr. Billy Dunn, director of the Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research, said in a statement. “This treatment option is the latest therapy to target and affect the underlying disease process of Alzheimer’s, instead of only treating the symptoms of the disease.”
Lecanemab will be marketed as Leqembi, the FDA statement said. It has shown “potential” as an Alzheimer’s disease treatment by appearing to slow progression, according to Phase 3 trial results, but it has raised safety concerns due to its association with certain serious adverse events, including brain swelling and bleeding.
If those trials confirm that the drug provides a clinical benefit, the FDA could grant traditional approval. But if the confirmatory trial does not show benefit, the FDA has the regulatory procedures that could lead to taking the drug off the market.
The Association Between Smoking And Alzheimers Disease: Effects Of Study Design And Bias
- Walter A KukullCorrespondenceAddress reprint requests to Walter Kukull, University of Washington, Department of Epidemiology, Box 357236, School of Public Health and Community Medicine, Seattle WA 98195-7236Affiliations
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An Offer He Couldnt Refuse: Reporter Phil Gutis Interviews Joanne Pike On Her First Day As Ceo Of The Alzheimers Association
Joanne Pike, new CEO of the Alzheimers Association as of 2023, spoke with Being Patient reporter Phil Gutis in her first interview on the job.
As any reporter will tell you, the pitches from public relations folks can be ceaseless. But late last year, I received an offer I couldnt refuse. It came from the Alzheimers Association, and it was an offer to do the first interview with Joanne Pike on the day that she became the associations president and CEO.
The email explained that they thought it was appropriate to offer Pikes first interview as CEO to a writer like me, who is living with Alzheimers. As they probably anticipated, I couldnt agree more.
Pike, who holds a doctorate in public health leadership, has spent her entire career in health policy advocacy. She joined the Alzheimers Association in 2016, overseeing care and support services outreach aimed at creating partnerships with health systems and physicians. She has also served as the associations chief strategy officer. Pike takes over from Harry Johns, who served as the Associations lead executive since 2005.
Pike assumes leadership of the association at what she terms a pivotal moment for Alzheimers research, potential for new treatments, and what that means for how we provide care long term.
Pike responded to critics who thought it was inappropriate for the association to push so hard for approval of aducanumab.
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Fda Approves Eisais Lecanemab For The Treatment For Alzheimer Disease
The FDA has approved lecanemab , a humanized IgG1 monoclonal antibody that binds with high affinity to amyloid-ß soluble protofibrils, for the treatment of patients with early-stage Alzheimer disease . Marketed as Leqembi, it becomes the second antiamyloid therapy in its class, joining aducanumab , which earned approval in June 2021 and was developed by Biogen, which also partnered with Eisai on lecanemab’s development.1
“Ultimately, it adds to the treatment options beyond symptomatic therapy,” Marwan Sabbagh, MD, a behavioral neurologist Barrow Neurological Institute, and clinical investigator in the agent’s development program, told NeurologyLive®. “Patients are highly motivated to change their future. This is an important first step in transforming AD from a terminal disease to a chronic disease.”
Similar to its predecessor, lecanemab was greenlit via the accelerated approval pathway, with the application supported by data from the phase 2b proof-of-concept clinical trial, known as Study 201 . The pivotal phase 3 Clarity AD trial , which are anticipated to serve as supplementary data and are still pending review by the FDA, which the FDA noted it expects soon. In July 2022, when the FDA officially accepted and granted priority review to the biologics license application for lecanemab, the company claimed it would submit an application for traditional approval of the drug to the FDA.2
Omaha Alzheimers Association Encouraged By New Drug Research
OMAHA, Neb. As the Food and Drug Administration takes action on a new experimental drug meant to treat people who suffer from Alzheimers disease, a local organization is encouraged by its findings in trials and its potential future.
The drug is called Lecanemab. Researchers believe it appears to slow the progression of cognitive decline.
In Nebraska, there are 35,000 people older than 65 living with Alzheimers, according to the Alzheimers Association Nebraska Chapter.
The association expects that number to rise to 40,000 in the next two years.
Sharon Stephens is the Executive Director of the Nebraska chapter. Her father is 90 years old and suffers from Alzheimers.
The chance that we have a class of drugs thats going to make an impact early on is amazing, Stephens said. The second piece of that is that we know when a class of drugs is approved it opens the pipeline for other drugs. It builds momentum.
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Right now there is no cure for Alzheimers or dementia. However, Lecanemab is supposedly one of the first experimental drugs that have shown progress in slowing the neurological disease that causes the brain to shrink.
Its very exciting, Stephens said. This is a class of drugs that has an impact early on in the disease for those who have been diagnosed with mild cognitive impairment. It can give those suffering from MCI more time, and for us, that is a huge victory.
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This Drug Is Not For Everyone
The FDAs accelerated approval of lecanemab was expected, said Dr. Richard Isaacson, director of the Alzheimers Prevention Clinic in the Center for Brain Health at Florida Atlantic Universitys Schmidt College of Medicine.
Isaacson said lecanemab can be another tool in his toolbox to fight Alzheimers disease.
How Lecanemab Works
According to Medical News Today, lecanemab is a monoclonal antibody: a laboratory-created antibody used to treat certain diseases like cancer and Alzheimers and viruses like Covid by acting like antibodies made by the body. When introduced into the body, monoclonal antibodies are used to fight off infection, acting like the human immune system. Neurons play a vital role in the way the brain functions, helping out in areas like communication and regeneration. However, in brains with Alzheimers, neurons stop functioning and communicating with each other, ultimately leading to their death. As a result, plaque form, which can be very toxic to the brain, according to the National Institute on Aging. Lecanemab works by removing the plaque, slowing down the diseases progression. Lecanemab is reported to most robustly remove the amyloid plaques because it intervenes earlier in the pathological process that contributes to Alzheimers disease and with less side effects, Dr. Karen D. Sullivan, a board-certified neuropsychologist, told Medical News Today.
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