New Alzheimer’s Drug Leqembi Granted Full FDA Approval

The U.S. Food and Drug Administration today granted full approval for Leqembi (lecanemab-irmb) for the treatment of Alzheimer’s disease based on its ability to clear toxic amyloid from the brain. It is the first drug in the class of amyloid immunotherapies shown to slow cognitive decline and receive full FDA approval.

Leqembi can slow the cognitive decline associated with Alzheimer’s disease by 25%, according to data on the phase 3 clinical trial published by the drug’s developers, Eisai and Biogen. It is a monoclonal antibody infusion given every two weeks and is approved to treat affected individuals with earlier stages of mild cognitive impairment or mild dementia.

The drug was approved in January via the Accelerated Approval pathway but was not covered by Medicare or other insurers. In June an FDA Advisory Committee unanimously endorsed the efficacy and clinical benefit of Leqembi, voting that Eisai’s data demonstrated a clinical benefit to patients.

For individuals paying out of pocket, the cost of Leqembi is $26,500 a year, in addition to the cost of the medical tests needed to determine if amyloid is present in the brain, such as PET scans or spinal taps. However, Medicare announced in June it would broaden coverage for new Alzheimer’s drugs like Leqembi once the FDA grants traditional approval.

Starting today, individuals diagnosed with early cognitive impairment or mild dementia caused by Alzheimer’s disease under the care of a qualified physician will be eligible to receive drug coverage under Medicare Part B. 

Doctors who prescribe Leqembi will need to participate in patient registries for the drug to be covered by Medicare. These registries collect data such as patients’ demographics, diagnosis, and medical history. Doctors will also need to report whether the patients are taking medication for blood clots, and they must include any side effects that people taking Leqembi may experience. In addition, they will need to submit the results of brain scans and other tests that assess amyloid levels, an Alzheimer's protein that is the target of Leqembi.

Commercial health insurance plans may cover Leqembi. Plans may require prior authorization for a physician to obtain approval from the plan prior to prescribing the drug. Leqembi also offers a copay assistance program to help commercially insured people with their medication costs.

“Today’s announcement marks a critical step forward in the path toward a treatment for Alzheimer’s disease, giving hope to millions of individuals and families around the world,” said BrightFocus President and CEO Stacy Pagos Haller.

Alzheimer’s disease is the most common form of dementia, affecting more than 55 million people around the world.

Who is eligible?

To be eligible for the drug, patients must be diagnosed by a healthcare professional with mild cognitive impairment or mild dementia and have confirmed presence of amyloid plaque in the brain, which is typically detected through spinal taps or specialized PET scans. However, not all doctors perform spinal taps, which detect amyloid levels, and PET scans are not routinely covered by Medicare.

In December 2022, BrightFocus and 52 other organizations signed a letter asking President Biden to expand Medicare coverage to include greater access to amyloid-beta-detecting PET scans used to diagnose Alzheimer’s disease and to cover amyloid-lowering drugs such as Leqembi.

Blood tests to detect amyloid are available, including the PrecivityAD blood test (and the next-generation PrecivityAD2), which received critical early support from Alzheimer’s Disease Research, a program of BrightFocus Foundation. 

What are the risks?

With the 25% slowing of cognitive decline, Leqembi offers benefits that could allow individuals more time with their loved ones, although with those benefits come side effects that must be carefully explored by practitioners and patients.

People who carry a genetic risk for Alzheimer’s in the APOE4 gene are more vulnerable to brain swelling or bleeding known as ARIA (amyloid-related imaging abnormalities), which can be detected with regular brain scans and controlled through monitoring. The FDA’s approval includes a warning to doctors prescribing the drug about the risk of ARIA.

In addition, the phase 3 study revealed potential risks for those who have additional diseases and may already be taking other medications, which should be carefully monitored by a healthcare professional.

What’s next?

It’s unlikely that a single treatment or medication can cure Alzheimer’s on its own. Experts predict the future of Alzheimer’s treatment could resemble cancer care, in which patients are prescribed unique combinations of drugs to create personalized treatments that target their unique form of cancer.

For Alzheimer’s patients, this could include an amyloid-reducing drug like Leqembi paired with other future medications currently under development to remove tau ‘tangles,’ improve blood vessel health, or lessen brain inflammation, said Diane Bovenkamp, PhD, Vice President of Scientific Affairs at BrightFocus.

“We’re going to need an arsenal of drugs for what’s essentially personalized medicine,” Dr. Bovenkamp told the Boston Globe on January 1. “That’s why our multi-pronged research approach at BrightFocus Foundation is so critical; we have to meet the unique needs of every individual suffering from this disease.”

View Alzheimer’s disease resources and learn more about the Alzheimer’s research funded by BrightFocus Foundation’s Alzheimer’s Disease Research program.

About BrightFocus Foundation

BrightFocus Foundation is a premier global nonprofit funder of research to defeat Alzheimer’s, macular degeneration, and glaucoma. Through its flagship research programs — Alzheimer’s Disease Research, National Glaucoma Research, and Macular Degeneration Research — the Foundation has awarded nearly $300 million in groundbreaking research funding over the past 50 years and shares the latest research findings, expert information, and resources to empower the millions impacted by these devastating diseases. Learn more at brightfocus.org.

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