Authority gives the green light
First Alzheimer’s drug in the EU: How it works and who gets it
15.11.2024Reading time: 4 min.
For the first time, a therapy against Alzheimer’s is about to be approved in the EU. However, the drug called Lecanemab is only useful for certain patients.
In Germany alone, around a million people are affected by Alzheimer’s. The European Medicines Agency Ema has now given the EU the green light for the first time for an Alzheimer’s therapy that targets underlying disease processes. It recommends approval of the antibody lecanemab for the treatment of mild cognitive impairment (memory and thinking problems) or mild dementia in the early stages of Alzheimer’s disease.
Current Alzheimer’s therapies only treat symptoms of the disease, not causal processes in the brain. This is different with Lecanemab: The antibody is directed against so-called amyloid deposits in the brain and is intended to slow down the progression of the disease. However, this active ingredient is not about healing or improvement; such a remedy is still not in sight.
The main measure of effectiveness was change in cognitive and functional symptoms at 18 months, measured using a dementia rating scale. The scale ranges from 0 to 18,
If the amyloid plaques have already caused irreversible damage to the brain, removing them will no longer be of any use. According to Johannes Levin from the German Center for Neurodegenerative Diseases (DZNE), the first three years are considered the early Alzheimer’s phase. This currently probably affects at least 250,000 people in Germany. In this early phase, a sufferer can still cope very well on their own, but increasingly notices that their memory is failing.
However, there is another limitation to the Ema recommendation: the drug should only be used for Alzheimer’s patients who have only one or no copy of ApoE4, a specific form of the gene. They are therefore less likely to experience certain serious side effects – swelling and bleeding in the brain – than people with two ApoE4 copies.
Depending on the region, people with only one or no copy of ApoE4 make up between two thirds and 80 percent of Alzheimer’s patients, explained Gabor Petzold, director of clinical research at the DZNE. In Germany it is around 80 percent.
There are also other restrictive requirements – according to experts, not everyone with Alzheimer’s is a candidate for antibody therapy.
According to the World Health Organization (WHO), over 55 million people worldwide suffer from dementia, with Alzheimer’s accounting for approximately 75 percent of these cases. The disease leads to a progressive decline in cognitive function, characterized by memory loss and confusion. Read more about this here.
It will still be a few months before the drug can actually be used. In patients, Alzheimer’s disease must first be confirmed through biomarker tests, followed by a genetic test. The therapy is only an option for those affected with a preliminary stage or a very early stage of the disease.
In the next few days, however, a large number of inquiries from those affected and relatives to family doctors, Alzheimer’s centers and memory consultations can be expected, said Petzold. Johannes Levin fears an influx of tens of thousands of people even for the slightest forgetfulness. The diagnostic centers would hardly be able to handle such a flood of clarifications, he said.
Neurologist Özgür Onur from the University Hospital of Cologne also assumes that he can only treat relatively few patients with the new therapy each year, as frequent administration represents a major challenge. “I assume that we can treat 50 to 100 patients per year in Cologne. And we are a large center.”
Yes. In July, the EU Medicines Agency decided that the risk of serious side effects from the antibody was higher than the expected positive effect. The Eisai company then requested a second examination.
The Ema Human Medicines Committee has now concluded that in the limited population examined in the re-examination, the benefits of lecanemab in slowing the progression of disease symptoms are greater than the risks. In the first review, no subgroup analyzes were taken into account, but all patients.
What are the eligibility criteria for lecanemab treatment in Alzheimer’s patients?
Ousands of inquiries in the coming weeks. This surge may lead to a strain on healthcare providers as they work to assess whether patients qualify for treatment with lecanemab.
The anticipation surrounding the approval of lecanemab highlights the urgent need for effective Alzheimer’s therapies. As current options primarily address symptoms rather than the underlying disease, many patients and families are hopeful that this new drug will provide a meaningful benefit in managing the disease.
Understandably, the approval process includes several rigorous checks, ensuring that only those most likely to benefit from the therapy are treated. Medical professionals will need to navigate the complexities of eligibility, especially with the limitations surrounding the ApoE4 gene variant, which could impact a substantial portion of Alzheimer’s patients.
the introduction of lecanemab marks a significant step towards more comprehensive Alzheimer’s treatment options in Europe. While it represents progress in targeting the disease’s underlying causes, careful patient selection and monitoring will be crucial for maximizing its potential benefits.