The US Food and Drug Administration (FDA) has approved a new drug for Alzheimer’s disease. The drug Leqembi (with the active substance lecanemab) is the first to show that it can slow the deterioration of memory and thinking. – Now it will be exciting to see if EMA 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. If this preparation is approved by the EU’s Medicines Agency (EMA), it opens the door for use in Norway as well. According to preliminary data from a study published this autumn, the drug can slow cognitive impairment in Alzheimer’s patients by 27 percent over a period of 18 months. POSITIVE: Geir Selbæk, head of research at the National Center for Aging and Health and professor at the geriatric department at Oslo University Hospital. Photo: Aleksandr Nedbaev Can be offered in Norway Selbæk says it was not surprising that they approve lecanemab since the USA 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 a year. He says Norway tends to follow EMA’s recommendations. But whether the medicine will be offered in Norway is also a question of cost. Another issue is side effects. A side effect of the medication has been the risk of edema in the brain and possibly small brain haemorrhages. Selbæk says the latest medicine has shown less of this than the previous one, but that it will be a central question in the assessment in Europe and Norway. How it works In patients with Alzheimer’s, plaques (protein deposits) form in the brain which are toxic to the brain cells. It destroys the communication between the brain cells. The first preparation to be approved in the US (aducanemab) was shown to reduce these plaques. But it could not be documented that it had an effect on Alzheimer’s symptoms, such as memory. The new thing about lecanemab is that it both reduces plaque formation AND that it showed an effect against Alzheimer’s symptoms. Although it was a small effect. – Just the fact that you have a medicine that shows an effect is a really big breakthrough. And it gives hope to so many. And that is incredibly important, says Selbæk. He says the first step is very important, and points out that it took 20-25 years from when you had medicines that showed an effect against cholesterol until you have medicine with a very good effect. Must be treated early – Who can get this medicine? – There are people with mild cognitive impairment (that is, before one has dementia) and mild dementia with Alzheimer’s disease. It is a medicine that must be given early in the course, so it is absolutely essential to be able to find these people. The hope is that markers can be found using a simple method, such as blood tests. – You should preferably start with the medicine before you start to remember poorly, says Selbæk. When the US agreed to acunemab, it was with a caveat. Within ten years, they had to document an effect against Alzheimer’s (not just that it prevented plaque in the brain). The approval of lecanemab has no reservations. Thus, there is a greater probability that it can also be approved in Europe.
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Promising Alzheimer’s medicine approved in the USA – news Urix – Foreign news and documentaries
