- Lecanemab (aka leqembi) has received full approval from the United States Food and Drug Administration.
- It is the first treatment approved by the FDA to help slow the progression of Alzheimer’s disease.
- Doctors recommend having a thorough conversation with your doctor about the risks and benefits.
Big news in the fight against Alzheimer’s disease: the first drug proven to slow the progression of the devastating disease type of dementia has just received full approval from the United States Food and Drug Administration (FDA).
Lecanemab (which is sold under the brand name Leqembi) helps reduce amyloid plaques in the brain that are hallmarks of Alzheimer’s disease. The drug was approved in January under the aegis of the FDA Accelerated approval path, which allows the organization to approve drugs for serious conditions when there is an unmet medical need, based on clinical data demonstrating the drug’s effect on a surrogate endpoint. But the FDA required a clinical trial to verify the benefits and effectiveness of lecanemab.
“Today’s action is the first verification that a drug targeting the underlying disease process of Alzheimer’s disease has shown clinical benefit in this devastating disease,” said Teresa Buracchio, acting director of the FDA Center for Drug Evaluation and Research Office of Neuroscience. A statement. “This confirmatory study confirmed that it is a safe and effective treatment for patients with Alzheimer’s disease.”
Approval will not only open the drug to people who need it, it may also be affordable. THE Medicare and Medicaid Service Centers said Thursday that it would include lecanemab in its coverage. This is great news, because without coverage, the annual cost of treatment could be more than $26,000.
Alzheimer’s disease affects nearly 6 million Americans, and more people are expected to be diagnosed with the disease in the future. Centers for Disaster Control and Prevention (CDC) says. It is also the sixth leading cause of death in the country. There is currently no cure for the disease, but experts say this new treatment can help patients have a better quality of life.
With current events, it’s understandable to have questions about what lecanemab is and how it works. Here’s what you need to know.
What is lecanemab (leqembi)?
Lecanemab (aka Leqembi) is the first amyloid-beta antibody to move from accelerated to traditional approval for the treatment of Alzheimer’s disease, the FDA explains. The drug works by reducing the amyloid plaques that form in the brain, which is a hallmark of Alzheimer’s disease. With this, it helps in slowing down the progression of the disease.
Lecanemab is given to patients by IV infusion.
How effective is lecanemab (leqembi)?
There have been several studies on lecanemab and its effectiveness.
The results of a phase 3 clinical trial conducted at 235 different medical sites in North America, Europe and Asia, which have been published in the New England Journal of Medicine found that lecanemab reduced cognitive and functional decline by 27% in patients with Alzheimer’s disease. He also found that patients taking the drug had more amyloid plaques cleared after 18 months of treatment.
The trial, which included 1,795 adults aged 50 to 90 with mild cognitive impairment due to early stage Alzheimer’s disease or mild Alzheimer’s disease-related dementia, pooled participants into those who were assigned to receive lecanemab by IV infusion every other week or placebo.
Participants in both groups had a clinical dementia rating of about 3.2 at the start of the trial. At the end of the 18-month trial, the score increased by 1.2 points in the group that received lecanemab, but it increased by nearly 1.7 points in the placebo group. (Note: a higher score means someone has more cognitive impairment.)
Amyloid levels were also tracked. The mean amyloid level was 77.92 centiloids in the lecanemab group and 75.03 centiloids in the placebo group. At the end of the trial, mean levels dropped to 55.48 centiloids in the lecanemab group and increased by 3.64 centiloids in the placebo group.
The latest study, called Study 301, was a multicenter, randomized, double-blind, placebo-controlled, parallel-group study that enrolled 1,795 patients with Alzheimer’s disease. Patients were randomly assigned to receive 10 milligrams of lecanemab every two weeks or a placebo.
The FDA states that lecanemab “demonstrated a statistically significant and clinically significant reduction in decline from baseline to 18 months on the primary endpoint” compared to a placebo.
Side effects of lecanemab (leqembi)
It is important to note that lecanemab is not perfect. “There are major risks associated with bleeding and swelling in the brain,” says Amit Sachdev, MD, medical director of neurology and ophthalmology at Michigan State University and principal investigator of the lecanemab clinical trial program at Michigan State University. (Dr. Sachdev has been caring for patients taking the drug since 2019.) “These risks need to be considered very carefully,” he adds.
The latest study found that the most common side effects of lecanemab were:
- Infusion-related reactions
- Amyloid-related imaging abnormalities (ARIA)
The FDA points out that ARIA most commonly manifests as temporary swelling in areas of the brain seen in imaging studies that typically resolves over time and may occur alongside small bleeding spots in or at the brain surface.
ARIA can also be accompanied by severe and life-threatening cerebral edema (swelling of the brain) which may be linked to seizures and other serious neurological symptoms. Intracerebral hemorrhages (ie bleeding in the brain) can occur and be fatal. Therefore, a boxed warning is included in the prescribing information.
The drug’s Phase 3 clinical trial found that lecanemab caused infusion-related reactions in over 26% of patients and ARIA in 12.6% of patients. More than 17% of people in the lecanemab group had a brain haemorrhage (compared to 9% of those in the placebo group).
“Patients will need strong evidence that they have Alzheimer’s disease and will need easy access to emergency care if they choose to take the drug,” says Dr. Sachdev. “Brain swelling and bleeding are very serious side effects and minor neurological symptoms such as dizziness and headaches may be due to such swelling.”
How much will lecanemab (leqembi) cost?
It’s not clear at the moment. However, Medicare and Medicaid covering the drug indicate that it should become affordable – or relatively affordable – for a wide range of people. Without coverage, the annual cost of treatment could be more than $26,000.
What does FDA approval mean?
It is the first drug proven to slow the progression of Alzheimer’s disease, making it a breakthrough treatment. His approval is also a big issue.
“Full FDA approval is very difficult to obtain,” says Dr. Sachdev. “It’s the gold standard for a cure.” If a drug is experimental, you don’t expect insurance to cover it, he points out. But now that it’s approved, it’s “at least possible” that insurers will consider covering lecanemab, he says.
Actual impact on patients may vary. “For patients who are later in their disease, this may not have a big impact,” says Dr. Sachdev. “For patients earlier in their disease, this could be a useful tool to slow progression.”
Now that the drug is approved, it’s important for patients to talk to their doctors, says David Merrill, MD, Ph.D., geriatric psychiatrist and director of the Pacific Brain Health Center at the Pacific Neuroscience Institute in Santa Monica, California. “This drug is complicated,” he says. “For some, it can slow down how quickly they get worse, but it comes with risks. It is not a simple decision. It must be a shared decision.
Dr Merrill says there are “still a lot of questions about who will benefit from this treatment and what will help people get better”.
Paul Newhouse, MD, clinical director of the Vanderbilt Alzheimer’s Disease Research Center, said it could take a few months before lecanemab can be administered in major medical centers. “It’s going to take us some time to put in place a procedure for this to be administered – there are many steps to follow,” he says. “We need to screen patients properly, get patients genetically tested, and then put the infrastructure in place to administer that properly. We must also confirm that the patient has elevated levels of beta-amyloid in the brain before starting this treatment.
While lecanemab carries a risk of potentially serious side effects, Dr. Sachdev says he is “excited” for patients and their families. “The medication is far from perfect, but having the chance to have a discussion is remarkable,” he says.
Korin Miller is a freelance writer specializing in general wellness, health and sex, and lifestyle trends, with work appearing in Men’s Health, Women’s Health, Self, Glamour, and more. She has a master’s degree from American University, lives near the beach, and hopes to one day own a teacup pig and a taco truck.