New drug against him Alzheimer’s disease in United States of Americawill soon be on the market and is the first drug that, according to official data, can slow the progression of the disease for several months.

But, despite the fact that the need for the drug in question has existed for a long time, experts recommend taking great care, since, as they say, it is not a medicine and is intended only for the early stages of the disease. Many even express concerns about the safety of the drug, which is administered intravenously every two weeks.

In addition, it is not yet clear to what extent the benefits of the drug will be felt in the daily life of patients.

However, “this is an important milestone,” says Dr. Richard Hodes, head of the US National Institute on Aging. “It’s not enough, but it’s an encouraging sign that we can do something.”

So what do we know about lekanemab, which will be sold under the brand name Lekambi?

How it works;

The drug, created by the Japanese company Eisai in collaboration with the American Biogen, is designed to find and remove a sticky protein called B-amyloid, which creates a kind of plaque that clogs the brain.

The drug targets a slightly different form of this amyloid protein, which explains why it was successful in intensive research when a long list of previous drugs failed. Sam Gandy is an Alzheimer’s Specialist at Mount Sinai Hospital in New York.

The FDA also approved a similar drug called Adulhelm in 2021, although studies have never shown it actually helps patients, drawing heavy criticism from the congressional investigation.

How effective is it?

In Eisai’s 18-month study of about 1,800 people, Lekambi slowed the deterioration of patients in the early stages of the disease by about five months.

The calculation was made on an 18-level scale, which tracked the cognitive and functional abilities of the participants. People who were given the drug got worse, but not as quickly as those who received the dummy dose.

Experts disagree on whether this is a significant benefit or not. It can be difficult for patients’ families to tell if the progression of the disease has slowed, Gandhi said.

Other experts say slowing down the disease early, while patients are still functional, is important, even if the difference isn’t easy to see.

“A few months [παραπάνω] with better cognitive abilities, doesn’t that matter?” Hodes says. “I think it’s a strong argument that if I can interact with my family and be independent for a few months… that’s a very meaningful outcome.”

What are the risks?

Like other similar medicines, Lekambi may cause swelling of the brain or slight bleeding. In Eisai’s study, edema was observed in 13% of participants taking the drug, and minor cerebral hemorrhages in 17%.

The most likely reason for this is that amyloid plaques usually form around nerve cells in the brain, and sometimes this sticky substance reaches the blood vessels. Gandhi explains that removing it from them can weaken them, making them prone to leaks.

Also, while swelling and bleeding may only cause symptoms such as dizziness and vision problems, it is possible that they can sometimes be more serious. Several Leqembi users have died while taking the drug, including two people who were also given anticoagulants.

Eisai says these deaths cannot be related to the Alzheimer’s drug. But Gandhi says the greatest risk of serious bleeding will be in Lekambi users who are also taking anticoagulants, which are often used by older people to prevent or treat strokes.

It has even been noted that after administration of the drug, patients may experience symptoms such as fever, chills, nausea, and fluctuations in blood pressure.

Who can enter it?

The drug is intended only for patients in the very early stages of Alzheimer’s disease who have an accumulation of amyloid protein in the brain.

The FDA is warning doctors to be careful when prescribing the drug to people taking anticoagulants. In addition, patients are advised to undergo several brain tests during treatment.

As the condition of patients will gradually worsen, it remains unclear how long they will need to continue taking the drug. Study participants will be followed for a longer period of time, while other studies are considering using the drug at an even earlier stage, before symptoms appear in patients with amyloid accumulation.

When will it be available?

Eisai estimates that the drug will be on the market by January 23, but it is likely that most patients will have to wait several months before receiving it.

The reason is that health insurance companies must evaluate the effectiveness of a drug before making a decision about coverage and for which patients.

Medicare, which covers most people with Alzheimer’s, is expected to pay for the drug only at the end of 2023. That’s because the seniors program only pays for Alzheimer’s drugs that have received full FDA approval, while in Lekambi’s case, the agency gave its approval through a shorter process based on preliminary study results. The FDA will review this study shortly, pending full approval later this year.

How much is it?

The drug will cost about $26,500 for a year of treatment.

If insurers cover this, then most people won’t pay that much, although there are times when the insured are forced to take on most of the costs, which can mean paying out thousands of dollars a year.

^{Source: Associated Press.}

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