The US Food and Drug Administration (FDA) has approved a new drug against
Alzheimer’s disease is a chronic disease of the brain and the most common cause of dementia. The disease always leads to dementia, and about 60 to 70 percent of people with dementia have it because of Alzheimer’s disease. The most typical symptom is impaired memory.
” data-term=”Alzheimer’s disease”>Alzheimer’s disease.
The medicine Leqembi (with the active substance lecanemab) it is the first to show that it can slow the deterioration of memory and thinking.
But the risk of side effects could stop approval in Europe.
– It will now be exciting to see the EMA (European Medicines Agency) approves it for Europe. Because there is still no medicine that has been approved here, says Geir Selbæk, head of research at the National Center for Aging and Health.
Is this preparation approved by the EMA?also opens it for use in Norway.
According to preliminary data from a study released this fall, the drug can slow cognitive impairment in Alzheimer’s patients by 27 percent over an 18-month period.
POSITIVE: Geir Selbæk, head of research at the National Center for Aging and Health and a professor at the department of geriatrics at Oslo University Hospital.
Photo: Alexander Nedbaev
It can be offered in Norway
Selbæk says it wasn’t surprising that they approve lecanemab since the US has already approved a medicine with less effect (aducanemab).
Selbæk says he has heard of Europeans who have already gone to the United States to get medicine. The treatment is given as an injection once every four weeks and costs between NOK 500,000 and 1 million annually.
He says Norway tends to follow EMA recommendations. But whether the drug will be offered in Norway is also a question of cost.
Another problem is the side effects.
There was a risk of a side effect from the drug
Increased tissue fluid in the body cavity.
” data-term=”edema”>edema in the brain and possibly small brain hemorrhages. Selbæk says the latest drug showed less of this than the previous one, but that it will be a central question in the assessment in Europe and Norway.
Here’s 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 preparation to be approved in the United States (aducanemab) has been shown to reduce these plaques. But it could not be documented that it had an effect on Alzheimer’s symptoms, such as memory.
The novelty of lecanemab is that it both reduced plaque formation and showed an effect against the symptoms of Alzheimer’s. Even if it was a small effect.
– Just having a medicine that shows an effect is really a big step forward. And it gives hope to many. And that’s incredibly important, says Selbæk.
She says the first step is very important and points out that it took 20-25 years from having medicines that showed an effect against cholesterol until you had medicines with a very good effect.
It must be treated in advance
– Who can get this medicine?
– There are people with mild cognitive impairment (that is, before having dementia) and mild dementia with Alzheimer’s disease. It is a medicine that must be administered at the beginning of the course, so it is absolutely essential to be able to find these people. The hope is that the markers can be found using a simple method, such as blood tests.
– Ideally you should start on the drug before you start misremembering, Selbæk says.
When the United States accepted aducanemab, it was with one caveat. Within ten years, they had to document an effect against Alzheimer’s (not just the prevention of plaque in the brain).
The approval of lecanemab has no caveats.
Dermatosis there is a greater probability that it can also be approved in Europe.
But FDA approval comes after urgent treatment. The earlier approval of the Alzheimer’s medicine has received a lot of criticism, and Selbæk notes that the FDA is much more liberal than the European authorities.
