WASHINGTON (AP) — A new drug for Alzheimer’s disease is hitting the market — the first with clear evidence it can slow the mind-robbing disease by months.
It’s a new treatment that’s been needed for a long time, but experts also express a lot of caution: the drug is not a cure, it’s only for early-stage patients, requires IV doses every every two weeks and raises security issues.
It’s not even clear how noticeable it is 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 to see that we can do something.”
Here are some things to know about the Food and Drug Administration Approval of lecanemab, marketed under the Leqembi brand:
HOW DOES THE NEW MEDICINE WORK?
The drug, made by Japan’s Eisai and its US partner Biogen, is designed to target and eliminate a sticky protein called beta-amyloid that builds up in brain-clogging plaques – a key hallmark of Alzheimer’s disease.
It targets a slightly different form of this amyloid, perhaps explaining why it proved effective in a rigorous study when a long list of previous amyloid-targeting drugs has failed, said specialist Dr. Sam Gandy. of Alzheimer’s disease at Mount Sinai Hospital in New York.
The FDA cleared a similar drug named Aduhelm in 2021, even though studies never proved it really helped patients, a move that sparked scathing criticism from a congressional inquiry.
HOW EFFECTIVE IS IT?
In Eisai’s 18-month study of nearly 1,800 people, Leqembi appeared to delay early-stage patients getting worse by about five months.
This was measured on an 18-point scale that tracks cognitive and functional abilities. People who received the drug got worse again, but not as quickly as those who received dummy versions – a difference of nearly half a point on this scale by the end of the study.
Experts are divided on the importance of a benefit. 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 disease early on, when people are still functioning well, even if it’s not so easy to spot.
“Several months with better cognition, what’s that worth to you?” Hodes asked. “I think there you can get a strong argument: if I can interact with my family, be independent for months…that’s a very meaningful outcome.”
WHAT ARE THE RISKS ?
Like other amyloid-targeting medicines, Leqembi may cause brain swelling or small brain bleeds. In Eisai’s study, 13% of addicts had swelling and 17% had small brain bleeds.
The likely reason: Amyloid plaques usually form around nerve cells in the brain, but sometimes gunk gets into blood vessels as well. Extracting amyloid from these blood vessels can weaken them, making them leaky, Gandy explained.
Although brain swelling and bleeding only cause minimal symptoms such as dizziness and vision problems, they can sometimes be serious – 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 for Leqembi users who are also taking blood thinners, which are commonly used by older people to prevent or treat strokes.
Patients may also experience temporary reactions after the infusions, including fever, flu-like chills, nausea, and fluctuations in blood pressure.
WHO IS ELIGIBLE?
The drug is only for people in the very early stages of Alzheimer’s disease who also have this telltale amyloid buildup.
The FDA has warned doctors to exercise caution if prescribing Leqembi to people who use blood thinners. Patients will also be asked to have brain scans several times during treatment.
As patients get worse, it’s unclear how long they should continue to receive the twice-monthly intravenous infusions. Study participants are being followed for longer periods of time, and further research is exploring even earlier use — before people with amyloid buildup 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 for it.
This is because health insurers are supposed to look at the effectiveness of the drug before deciding whether to cover it, for which patients and what tests they may require to confirm they are good candidates.
And Medicare, which covers most people with Alzheimer’s disease, isn’t expected to pay for the drug until the end of the year. That’s because the seniors’ plan only pays for Alzheimer’s drugs that have received full FDA approval, while the agency grants Leqembi approval using an outcome-based shortcut. preliminary studies. The FDA is expected to review this larger 18-month study soon, in anticipation of full approval later this year.
HOW MUCH WILL THE MEDICINE COST?
The IV drug 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 cover more of their drug costs could be paying thousands a year.
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The Associated Press Health and Science Department is supported by the Howard Hughes Medical Institute Science and Education Media Group. The AP is solely responsible for all content.
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