The US Food and Drug Administration (FDA) has approved a new drug against Alzheimer’s disease.
Leqembi medicine (with the active ingredient lecanemap) It is the first to show that it can slow down the decline of memory and thinking.
But the risk of side effects may stop approval in Europe.
– Now it will be interesting to see the EMA (European Union Medicines Agency) approved by Europe. It’s because there’s still no drug approved here, says Geir Selbeck, chief of research at the National Center on Aging and Health.
Is this setup approved by EMAIt also opens for use in Norway.
According to preliminary data from a study published this fall, the drug can slow cognitive impairment in Alzheimer’s patients by 27% over 18 months.
It can be submitted in Norway
Selbæk says it wasn’t It is surprising that they approved lecanemab because the US has already approved a drug that has a lower effect (aducanemab).
Selbæk says he’s heard of Europeans who actually went to the United States to get the medicine. The treatment is given as an injection once every four weeks, and costs between NOK 500,000 and NOK 1 million per year.
He says Norway tends to follow the EMA’s recommendations. But whether the drug will be offered in Norway is also a matter of cost.
Another issue is side effects.
There is a risk of side effects from the medication edema; In the brain, perhaps Small cerebral hemorrhage. Selbæk says the latest drugs have shown less than previously, but that this will be a central question in the evaluation in Europe and Norway.
This is how it works
In Alzheimer’s patients, plaques (protein deposits) form in the brain that are toxic to brain cells. It destroys communication between brain cells.
The first drug approved in the United States (aducanemab) has been shown to reduce these plaques. But its effect on Alzheimer’s symptoms, such as memory, cannot be documented.
The new thing about lecanemab is that it reduced plaque formation and showed an effect against Alzheimer’s symptoms. Although it was a small effect.
– Just the fact that you have a drug that shows an effect is really a huge breakthrough. It gives hope to many. And that’s very important, says Selbeck.
The first step is very important, he says, and points out that it took 20-25 years from the time you took drugs that showed an effect against cholesterol until you had a drug that had a very good effect.
It must be treated early
– Who can get this medicine?
– There are people with mild cognitive impairment (i.e. before developing dementia) and mild dementia with Alzheimer’s disease. It’s a drug that needs to be given early in the cycle, so it’s absolutely essential to be able to find these guys. The hope is that the signs can be found using a simple method, such as blood tests.
– You should ideally start with medication before you start to remember poorly, says Selbæk.
When the US approved Aducanemab, it was with a caveat. Within ten years, they were to document an effect against Alzheimer’s disease (not only that it prevents plaque in the brain).
consent lecanemab has no warning.
So There is a higher chance that it will also be approved in Europe.
But FDA approval takes place after urgent treatment. Previous approval of a drug against Alzheimer’s disease has received a lot of criticism, and Selbeck notes that the FDA is much more liberal than European authorities.
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