New Alzheimer’s Drug Granted Accelerated FDA Approval

The drug was shown to slow cognitive decline in patients by clearing toxic amyloid from the brain.
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The U.S. Food and Drug Administration today approved Leqembi (lecanemab-irmb) via the Accelerated Approval pathway for the treatment of Alzheimer’s disease based on its ability to clear toxic amyloid from the brain. It is the only drug in the class of amyloid immunotherapies shown to slow cognitive decline and will be available during or before the week of Jan. 23, 2023. 
 
The drug, a monoclonal antibody infusion given every two weeks, is approved to treat affected individuals with earlier stages of mild cognitive impairment or mild dementia. 

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

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. 

“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.  

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. 

How much will it cost? 

Eisai said Leqembi would launch at an annual out-of-pocket cost of $26,500; amyloid-lowering drugs are currently not covered by Medicare or other insurers.  

Eisai stated that it has patient support and assistance available.  

What’s next? 

Using the recently published data from the large global confirmatory Phase 3 clinical trial, Clarity AD, Eisai will work quickly to file a Supplemental Biologics License Application (sBLA) to the FDA for approval under the traditional pathway. 

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 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 is currently supporting a $75 million portfolio of 287 scientific projects. BrightFocus has awarded nearly $275 million in groundbreaking medical research funding since inception and shares the latest research findings, expert information, and English/Spanish disease resources to empower the millions impacted by these devastating diseases.  Join our community at brightfocus.org.

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