WASHINGTON – A new Alzheimer’s drug is coming to market – the first with clear evidence it can slow down the mind-numbing disease by several months.
It’s a long-needed new treatment, but experts are also voicing great caution: the drug isn’t a cure, it’s only intended for early-stage patients, requires an IV dose every two weeks, and comes with some safety concerns.
It’s not even clear how noticeable this is modest benefit will be in people’s everyday lives.
Still, “it’s a milestone,” said Dr. Richard Hodes, Director of the National Institute on Aging. “It’s not enough, but it’s encouraging that we can do something.”
Here are some things you should know about the Food and Drug Administration approval of lecanemab to be sold under the brand name Leqembi:
HOW DOES THE NEW DRUG WORK?
The drug, made by Eisai of Japan and its US partner Biogen, is designed to target and eliminate a sticky protein called beta-amyloid, which builds up into brain-clogging plaques – a key feature of Alzheimer’s disease.
It targets a slightly different form of this amyloid, which may explain why it has proven successful in a rigorous study when a long list of previous amyloid-targeted drugs have failed, said Dr. Sam Gandy, an Alzheimer’s specialist at New York’s Mount Sinai Hospital.
The FDA approved a similar drug called Aduhelm in 2021, though studies never proved it actually helped patients, a move that drew scathing criticism from a Investigation of Congress.
HOW EFFECTIVE IS IT?
In Eisai’s 18-month study of nearly 1,800 people, Leqembi appeared to delay deterioration by about five months in early-stage patients.
This was measured on an 18-point scale that captures cognitive and functional abilities. People given the drug still got worse, but not as quickly as those given sham versions — a difference of almost half a point on this scale at the end of the study.
Experts are divided on how useful an advantage is. It can be difficult for families to tell if a loved one’s decline has slowed, Gandy said.
Other experts say it’s important to slow the disease down early when people are still functioning well, even if it’s not that easy to spot.
“Several months of better perception, what’s that worth to you?” asked Hodes. “I think you can get a strong argument there: if I can interact with my family, be able to be independent for months… that’s a very meaningful outcome.”
WHAT ARE THE RISKS?
Like other amyloid medicines, Leqembi can cause brain swelling or small bleeding in the brain. In Eisai’s study, 13% of drug users had swelling and 17% had small cerebral hemorrhages.
The likely cause: Amyloid plaques usually form around nerve cells in the brain, but sometimes the gunk also finds its way into blood vessels. Pulling amyloid out of these blood vessels can weaken them and cause them to leak, Gandy explained.
While the brain swelling and bleeding can cause only minimal symptoms, such as dizziness and blurred vision, it can occasionally be severe – and several Leqembi users have died while taking the drug, including two who were taking blood-thinning medication.
Eisai has said the deaths cannot be attributed to his Alzheimer’s drug. However, Gandy said the greatest risk of serious bleeding is among Leqembi users who also take blood thinners, which are commonly used by older adults to prevent or treat stroke.
Patients may also experience transient reactions after the infusions, which may include fever, flu-like chills, nausea, and changes in blood pressure.
WHO IS ELIGIBLE?
The drug is only for people in the very early stages of Alzheimer’s who also have this tell-tale amyloid buildup.
The FDA warned doctors to exercise caution when prescribing Leqembi to people using blood thinners. Patients are also asked to have brain scans multiple times over the course of treatment.
As the patients’ condition gradually worsens, it is not clear how long they should receive the twice-monthly intravenous infusions. Study participants are being followed over longer periods of time, and other research is investigating even earlier use — before people with amyloid build-ups show symptoms.
WHEN WILL IT BE AVAILABLE?
According to Eisai, the drug should be available by January 23, but most patients will likely have to wait months to get it.
That’s because health insurers are expected to test the drug’s effectiveness before deciding whether to cover it, for which patients, and what tests they might need to confirm they’re good candidates.
And Medicare, which covers most people with Alzheimer’s, isn’t expected to pay for the drug until later this year. That’s because the plan for seniors only pays for Alzheimer’s drugs that have been fully approved by the FDA — while the agency approved Leqembi with an abbreviation based on preliminary study results. The FDA will soon review this larger 18-month study, pending full approval later this year.
HOW MUCH WILL THE DRUG COST?
The IV drug costs about $26,500 for a typical year’s treatment. When insurers pay for it, most people don’t pay nearly as much — although people with insurance that requires them to pay a larger chunk of their medication costs could pay thousands a year.
___
The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Science and Educational Media Group. The AP is solely responsible for all content.
Copyright 2023 The Associated Press. All rights reserved. This material may not be published, broadcast, transcribed or redistributed without permission.
