The European Commission For the first time, therapy to combat the disease processes has been approved by Alzheimer’s diseases. The antibody Lecanemab, which is supposed to treat the disease in the early stage and be able to slow down a little, could therefore be available in a few months. According to experts, however, only a very small part of the Alzheimer’s sufferer is considered for therapy.
According to the EU Commission, Lecanemab is the first drug this kind that was approved in the EU. The release of strict requirements, but overall it was concluded that the benefits of the medication in a certain group of patients and under certain prerequisites predominate the risks.
With the approval, the EU Commission follows the Recommendation of the European Medicines Agency (EMA)that had released the therapy in November 2024.
Medium slowdows Alzheimer’s detectable
Previous Alzheimer’s therapies only treat the symptoms of the disease. However, Lecanemab already starts at the causal processes in the brain: the antibody acts against the amyloid deposits in the brain and is therefore supposed to slow down the course of the disease in an early stage. However, this also causes this Active ingredient No healing or real improvement.
The effectiveness of the therapy was assessed in advance using measurements of cognitive and functional symptoms after 18 months. The changes in this area were measured based on a dementia assessment scale that ranges from 0 to 18. Patients treated with Lecanemab therefore showed a slightly lower increase in symptoms as those affected without treatment with the active ingredient in the same period (1.22 to 1.75).
Many uncertainties
However, this does not necessarily mean that Lecanemab will be used broad in the future. Because there are still questions about the therapy. On the one hand, according to experts, it is questionable how relevant to everyday life is the delays to be achieved. The measured effect is usually no longer perceptible to the patients and their environment from a certain point, said Walter Schulz-Schaeffer from the Saarland University Hospital in Homburg. In women, the measured effects are significantly lower than in men. They also have a higher risk of side effects.
In addition, Lecanemab is only approved for the treatment of slight cognitive impairments (memory and thinking disorders) or easier dementia at an early stage of Alzheimer’s. The reason for this is that the intervention by the medication to the brain is no longer useful as soon as the disease caused irreversible damage. There are currently about 250,000 people in the early phase-the first three years-their Alzheimer’s disease.
In addition, there is another restriction: the remedy is only released for patients who have either a or no copy of the protein Apoe4. In these people, the likelihood of certain serious side effects, such as swelling and bleeding in the brain, is less than in humans with two APOE4 copies.
Application expected in a few months
According to experts from the German Center for Neurodegenerative Diseases (DZNE), this only applies to a small part of the 1.2 million people affected by Alzheimer’s in Germany. Of the 250,000 people in the early phase, around 80 percent would generally be possible with a view to APOE4, but only about ten percent of them are also interested in antibody therapy. In total, around 20,000 patients could actually receive the active ingredient.
According to estimates, it will take a few months before the medication can be used. First of all, capacities for treatment and detailed handouts and training for doctors would have to be worked out by the manufacturer and an observation register created. Lecanemab is administered intravenously every two weeks, and the costs amount to around 6,000 to 8,000 euros per patient annually, said Johannes Levin from the Dzne. In addition, there would be one -off costs for diagnostics in the amount of 1,400 to 5,000 euros.
