When you or someone you know is dealing with an incurable, progressive disease, it’s easy to see why the news of a new drug being approved would be exciting.
Drugs to slow the progression of Alzheimer’s disease are few and only provide a means to slow the progression of the neurological disease. Ideally, there would be a cure, but we’re not there yet.
On Jan. 6, the U.S. Food and Drug Administration granted accelerated approval to a drug called lecanemab, with a brand name of Leqembi, for patients who are confirmed to be in the early stages of Alzheimer’s disease.
In an 18-month study of nearly 1,800 people, the drug appeared to delay cognitive decline in early-stage Alzheimer’s patients by just over five months.
Not surprisingly, the Alzheimer’s Association praised the FDA approval.
“The Alzheimer’s Association welcomes and celebrates this action by the FDA,” Joanne Pike, association president and CEO, said in a news release. “We now have a second approved treatment that changes the course of Alzheimer’s disease in a meaningful way for people in the early stages of the disease.”
The FDA gave its approval to a similar drug named Aduhelm in 2021. Unfortunately, that drug has since triggered a congressional investigation about how it was approved.
Leqembi, which is being produced by Japan’s Eisai and its U.S. partner, Biogen, targets and gets rid of beta-amyloid, which is a sticky protein that builds up into plaques in the brain. Those proteins are a hallmark of Alzheimer’s disease and have been the focus of previous, unsuccessful research.
What does that mean for patients who are eligible for the drug?
“By slowing progression of the disease when taken in the early stages of Alzheimer’s, individuals will have more time to participate in daily life and live independently,” Pike said. “This could mean more months of recognizing their spouse, children and grandchildren. This could also mean more time for a person to drive safely, accurately and promptly take care of family finances, and participate fully in hobbies and interests.”
When you’re talking about a disease that robs a person of all those things, without the hope of ever recovering them, then even a small amount of extra time could be appealing.
Still, the new drug does come with some risks. Some of the drug recipients in Eisai’s study experienced brain swelling or small brain bleeds. The FDA has warned doctors to use caution if they prescribe Leqembi to patients who use blood thinners. Patients also will be urged to get brain scans over their course of treatment.
The drug also requires twice-a-month IV infusions that are expected to cost $26,500 for a year’s worth of treatment. Of course, those with insurance coverage won’t pay that. However, those with high deductibles could wind up paying thousands of dollars.
The Alzheimer’s Association is urging Medicare and insurance companies to act quickly to allow those who want the drug to get it as soon as possible. After all, Alzheimer’s patients only have a limited amount of time in that early stage, and it varies from patient to patient.
“While this news is exciting, without insurance and Medicare coverage of this class of treatments, access will be limited to only those who can afford to pay out of pocket,” Pike said. “The Alzheimer’s Association has submitted a formal request asking [Centers for Medicare and Medicaid Services] to remove the requirement that Medicare beneficiaries be enrolled in a clinical trial in order to receive coverage of FDA-approved Alzheimer’s treatments.”
Sadly, my Tony, who has early onset Alzheimer’s and is now in the middle stages of the disease, is not eligible for this new drug.
However, it remains an exciting development and one that provides a new option in an arena where so few currently exist.
• Joan Oliver is the former Northwest Herald assistant news editor. She has been associated with the Northwest Herald since 1990. She can be reached at jolivercolumn@gmail.com.