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Alzheimer’s Treatment Leqembi Gets Full FDA Approval

Research shows the medication can help slow the progression of the disease


spinner image Close up of a doctor wearing a blue surgical glove examining a brain scan on a computer screen
Andrew Brooks / Getty Images

The U.S. Food and Drug Administration (FDA) has granted, for the first time, full, traditional approval for an Alzheimer’s medication that is designed to do more than treat the symptoms of the memory-robbing disease. The drug, lecanemab (brand name Leqembi), was shown in clinical trials to help slow the progression of Alzheimer’s, which affects more than 6.5 million older Americans and for which there is no cure.  

“This is a big deal,” says Ronald Petersen, M.D., director of the Mayo Clinic Alzheimer’s Disease Research Center. Though there’s still work to do when it comes to finding medications that can treat Alzheimer’s, he says, “we’ve been waiting for this kind of breakthrough in the field for many, many years, and it’s a step in the right direction.” 

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The FDA granted lecanemab what’s known as accelerated approval in January. This fast-tracked approval process is reserved for drugs that treat serious conditions and appear promising based on preliminary evidence. In June, a committee of experts that advises the FDA voted in favor of fully approving lecanemab based on key findings from its large, late-stage clinical trial data.  

The medication, a monoclonal antibody, significantly reduced the amount of amyloid in the brain. (Amyloid, a protein that clumps together to form plaques that disrupt cell function, is a hallmark of Alzheimer’s disease.) It also slowed the rate of cognitive decline — or the loss of thinking and memory skills — in people with early to mild Alzheimer’s disease by 27 percent over an 18-month period.

Essentially, that means the medication “may preserve the person’s level of function for a longer period of time,” Petersen says. “You’re not stopping the disease, so people do not actually stay at their precise level, but they progress much more slowly,” he adds, noting that this could be especially helpful for someone in the early stages of Alzheimer’s who is still able to work, pay bills and live independently.

“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,” Teresa Buracchio, acting director of the Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research, said in a news release.

Another Alzheimer’s treatment that targets amyloid, called aducanumab (brand name Aduhelm), received accelerated approval from the FDA in 2021. However, this medication has not been fully approved.

Who can get the treatment?

Lecanemab is not for people with moderate or late-stage Alzheimer’s. The FDA has approved it only for people in the early stages (sometimes called mild cognitive impairment due to Alzheimer’s) and mild stages who have a confirmed presence of amyloid in the brain.  

Currently, the way health care providers check for amyloid is with a PET scan or a spinal tap, both of which are expensive and invasive. Researchers are making progress on blood tests that could be used to diagnose Alzheimer’s, but they are not yet available in most clinical settings.  

“They’re all just on the edge of getting out there,” says Jason Karlawish, M.D., a professor of medicine at the Perelman School of Medicine and codirector of the Penn Memory Center.

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Another limitation: The medication is given through an intravenous infusion every two weeks, which can be a barrier for people who lack transportation or live far from a hospital or infusion center.  

Side effects should be considered too. In studies, patients taking the medication reported everything from irritation at the infusion site to flulike symptoms to more serious events, including swelling and bleeding in the brain. Some of these bleeding events are small and detected only on an MRI scan; others are larger and can be fatal. “The drug has real benefits, but it also has real risks,” says Karlawish, who adds that patients will want to discuss their individual risks — from medications they may be taking to any genetic risk factors they may have — with their doctor before taking the treatment. Patients treated with lecanemab who have two copies of the ApoE4 allele have a higher risk of these more severe swelling and bleeding side effects. The same goes for those taking anticoagulant medications.

Finally, patients will need to work with a provider who is participating in what’s known as a registry to collect information on the safety and effectiveness of the medication. That’s because in June, the Centers for Medicare & Medicaid Services (CMS) announced that it will cover Alzheimer’s treatments that are fully approved by the FDA for people with Medicare Part B, as long as the health care provider is part of a registry. (In contrast, Medicare coverage for Alzheimer’s treatments under accelerated approval is limited to patients enrolled in clinical trials, as is the case for aducanumab.)

The CMS said in a news release that registries are common tools that have been used to gather information on patient outcomes for decades. Petersen notes that registry participation may be an additional hurdle for some doctors and could have “a slight impact on access.”

spinner image boxes and vials of the drug leqembi
Eisai via AP

Lecanemab’s drugmaker has priced the treatment at $26,500 a year, making it out of reach for many who don’t meet the coverage requirements and for those without insurance.

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Alzheimer’s research continues

While it’s exciting to have a new disease-modifying therapy for Alzheimer’s, Petersen says it’s important to keep in mind that lecanemab “is not a panacea” when it comes to treating the disease.

Researchers are studying additional amyloid-clearing drugs for Alzheimer’s treatment, as well as medications that attack different targets that fuel the disease process. Many experts predict it will take a combination of targeted therapies to conquer the disease.

“Hopefully, this [latest approval] is a stimulus for us to really continue doing this,” Petersen says about the research.

The health care system will also need some adjustments to accommodate the swell of older adults seeking diagnosis and treatment for Alzheimer’s, Karlawish says. By 2060, the number of Americans living with the disease is predicted to hit an estimated 14 million, according to the Centers for Disease Control and Prevention.

“This certainly is a net positive event and opens up a lot of opportunities for innovation,” Karlawish says.

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