A new Alzheimer’s drug is coming to market – the first with clear evidence that it can slow down the mind-robbing disease by months.
It’s a long-needed new treatment, but experts are also expressing a great deal of caution: the drug is not a cure, is only for early-stage patients, requires IV doses every two weeks and comes with some safety concerns.
It is not even clear how noticeable this modest benefit will be in people’s daily lives.
Still, “it’s a landmark,” said Dr. Richard Hodes, director of the National Institute on Aging. “It’s not enough, but it’s encouraging that there’s something we can do.”
Here are some things you should know about the Food and Drug Administration’s approval of lecanemab, to be sold under the brand name Leqembi:
HOW DOES THE NEW DRUG WORK?
The drug, made by Japan’s Eisai and its US partner Biogen, is designed to target and remove a sticky protein called beta-amyloid that builds up in brain-clogging plaques – one of the key signs of Alzheimer’s disease.
It targets a slightly different form of this amyloid, which may explain why it proved successful in a rigorous study, while a long list of previous amyloid-targeting drugs failed, said Dr. Sam Gandy, an Alzheimer’s specialist at Mount Sinai Hospital in New York.
The FDA approved a similar drug called Aduhelm in 2021, even though studies never showed it actually helped patients, a move that drew sharp criticism from a congressional inquiry.
HOW EFFECTIVE IS IT?
In an 18-month Eisai study of nearly 1,800 people, Leqembi appeared to delay deterioration in early-stage patients by about five months.
This was measured on an 18-point scale that tracks cognitive and functional abilities. People who got the drug still got worse, but not as quickly as those who got the fake versions — a difference of almost half a point on that scale by the end of the study.
Experts differ on how meaningful the benefit is. It can be difficult for families to know if a loved one’s decline has slowed, Gandy said.
Other experts say that slowing the disease early, when people are still functioning well, is important, even if it’s not as easy to spot.
“A few months with better knowledge, what’s that worth to you?” Hodes asked. “I think you can make a strong argument there: If I can communicate with my family, be independent for months … that’s a very meaningful outcome.”
WHAT ARE THE RISKS?
Like other drugs that target amyloid, Leqembi can cause brain swelling or small brain bleeds. In Eisai’s study, 13% of drug recipients had swelling and 17% had small brain bleeds.
Probable reason: Amyloid plaques usually form around nerve cells in the brain, but sometimes the gunk gets into blood vessels. Pulling amyloid out of these blood vessels can weaken them and make them leaky, Gandy explained.
While brain swelling and the bleeding can cause only minimal symptoms such as dizziness and vision problems, sometimes it can be severe – and several Leqembi users have died while taking the drug, including two who were taking blood thinners.
Eisai said the deaths could not be attributed to his Alzheimer’s drug. But Gandy said the greatest risk of serious bleeding would be among Leqembi users who also take blood-thinning drugs commonly used by older adults to prevent or treat strokes.
Patients may also experience temporary reactions after the infusions, which may include fever, flu-like chills, nausea, and fluctuations in blood pressure.
WHO CAUSED THEM?
The drug is only for people in the very early stages of Alzheimer’s who also have amyloid build-up.
The FDA has warned doctors to be careful if they prescribe Leqembi to people taking blood thinners. Patients will also be asked to have brain scans done several times during treatment.
As patients get progressively worse, it is not clear how long they should continue with the twice-monthly IV infusions. Study participants are being followed for longer periods of time, and other research is investigating even earlier use — before people with amyloid build-up show symptoms.
WHEN WILL IT BE AVAILABLE?
Eisai says the drug should be available by January 23, but most patients will likely have to wait months to receive it.
That’s because health insurance companies are expected to test a drug’s effectiveness before deciding whether to cover it, for which patients, and what tests they may require 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 senior plan only pays for Alzheimer’s drugs that have received full FDA approval — while the agency granted approval to Leqembi using a shortcut based on preliminary study results. The FDA is set to review this larger 18-month study soon, with the expectation of full approval later this year.
HOW MUCH WILL THE DRUG COST?
The IV drug will cost about $26,500 for a typical year’s treatment. If insurance companies cover it, most people won’t pay nearly as much — although people with insurance that requires them to cover a larger portion of drug costs could pay thousands a year.
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