February 9, 2023

WASHINGTON (AP) — A new Alzheimer’s drug is coming to market, the first with clear evidence that it can delay the mind-robbing disease by several months.

It’s a long-overdue new treatment, but experts are also warning: The drug is not a cure, is only intended for early-stage patients, requires intravenous dosing every two weeks, and has some safety concerns.

It’s not even clear how remarkable that modest benefit is. It will be in people’s daily 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 to know there’s something we can do.”

Here are some things to know about the Food and Drug Administration approval of lecanemab, which will be sold under the brand name Leqembi:

HOW DOES THE NEW DRUG WORK?

The drug, made by Japan’s Eisai and US partner Biogen, is designed to target and remove a sticky protein called beta-amyloid that accumulates in brain-clogging plaques, a key feature of Alzheimer’s disease.

It targets a slightly different form of that amyloid, which possibly explains why it succeeded in a rigorous study while a long list of previous drugs that target amyloid have failed, said Dr. Sam Gandy, an Alzheimer’s expert at the Mount Sinai Hospital in New York.

The FDA authorized a similar drug called Aduhelm in 2021 despite studies never showing it actually helped patients, a move that drew scathing criticism of a congressional investigation..

HOW EFFECTIVE IS IT?

In Eisai’s 18-month study of nearly 1,800 people, Leqembi appeared to delay worsening in early-stage patients by about five months.

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That was measured on an 18-point scale that tracks cognitive and functional abilities. People given the drug still got worse, but not as fast as those given dummy versions, a difference of almost half a point on that scale at the end of the study.

Experts are divided on how significant that benefit is. It can be hard for families to know if a loved one’s decline has slowed, Gandy said.

Other experts say delaying the disease early on, when people are still functioning well, is important, even if it’s not as easy to detect.

“Several months with better cognition, what is that worth to you?” Hodes asked. “I think you can make a strong argument there: if I can interact with my family, be independent for months… that’s a very significant result.”

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 those given the drug had swelling and 17% had small brain bleeds.

The likely reason: Amyloid plaques usually form around nerve cells in the brain, but sometimes dirt gets into blood vessels, too. Pulling the amyloid out of those blood vessels can weaken them and cause them to leak, Gandy explained.

While brain swelling and bleeds can cause only minimal symptoms, such as dizziness and vision problems, they can occasionally be severe, and several Leqembi users have died while taking the drug, including two who were taking blood-thinning medications.

Eisai has said the deaths cannot be attributed to his Alzheimer’s drug. But Gandy said the highest risk of serious bleeding would be among Leqembi users who also take blood thinners, which older adults often use to prevent or treat strokes.

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Patients may also experience temporary reactions after infusions that may include fever, flu-like chills, nausea, and fluctuations in blood pressure.

WHO IS ELIGIBLE?

The drug is only intended for people in the early stages of Alzheimer’s disease who also have that telltale amyloid buildup.

The FDA has warned doctors to be careful if they prescribe Leqembi to people using blood thinners. Patients will also be urged to have brain scans several times during the course of treatment.

As patients gradually worsen, it is not clear how long they should continue to receive the twice-monthly intravenous infusions. Study participants are being tracked for longer periods, and other research is exploring use even earlier, before people with amyloid buildup show symptoms.

WHEN WILL IT BE AVAILABLE?

Eisai says the drug should be available on January 23, but most patients will probably have to wait months to get it.

This is because health insurers are expected to review the efficacy of the drug before deciding whether to cover it, for which patients, and what tests they may require to confirm that they are good candidates.

And Medicare, which covers most people with Alzheimer’s, is not 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 an abbreviated method based on preliminary study results. The FDA is ready to review that larger 18-month study soon, in anticipation of full approval later this year.

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HOW MUCH WILL THE MEDICATION COST?

The IV medication will cost about $26,500 for a typical year of treatment. If insurers cover it, most people won’t pay as much, although people with insurance that requires them to bear more of their drug costs could pay thousands a year.

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The Associated Press Department of Health and Science receives support from the Howard Hughes Medical Institute Science and Educational Media Group. The AP is solely responsible for all content.