Doctors and patients have welcomed the European Medicines Agency’s (EMA) decision to recommend approval of the drug lecanemab for some patients in the European Union.
Last Thursday the EMA reversed course and recommended the use of lecanemab, under the trade name Leqembi, after having advised against it in July, believing that the side effects in Alzheimer’s patients did not compensate for the delay achieved in cognitive decline.
The EMA explanation
In a statement, the EMA specified that the granting of marketing authorization for the drug as a treatment for mild cognitive impairment or dementia resulting from Alzheimer’s is aimed at “patients who have only one copy or none of ApoE4, a certain form of the gene. of the protein apolipoprotein E”.
“Patients with a single or no copy of ApoE4 are less likely to experience amyloid-related imaging abnormalities (ARIA) than people with two copies of ApoE4. “AIR is a recognized serious side effect with Leqembi involving swelling and possible bleeding in the brain,” the EMA noted.
The medicine slows down the symptoms of the disease.
Patients, 20 years of waiting
Following the decision of the European body, the Spanish Alzheimer Confederation (Ceafa) He is pleased that people with Alzheimer’s have a new therapeutic tool “after more than 20 years of waiting.”
Patients are aware that “not all those affected will benefit” from lecanemab but believe that the EMA recommendation is “excellent news” and puts the EU on the same level as countries such as the United States, Japan, Korea South South or the United Kingdom, who have already given their approval.
“And although the 27% effectiveness may seem modest, the truth is that, compared to what exists today, it is very important,” underlines Ceafa in a note.
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Objective: approval and financing in Spain
He explains that this is an “important first step”, but adds that “there is still another that we must not forget: the approval by the Spanish Agency for Medicines and Health Products (AEMPS) and the inclusion of care in the service portfolio of the National Health System (SNS)“.
However, the foundation applauds what the EMA agreed and describes it as a “crucial advance” that affects “millions of people in Europe and around the world” and “opens a window of hope for patients and families”.
In his opinion, this reflects “the value of science and innovation in the search for solutions”: “It is a step that not only symbolizes progress, but also the commitment to improve the quality of life of those who face this reality” , he keeps.
Controlled access program
For his part, the Spanish Society of Neurology (SEN) He also highlighted the European body’s decision and appreciates that it made a recommendation similar to that of other regulatory agencies.
Likewise, he shares that the EMA limits the drug to patients with a higher risk of complications, such as those who have two copies of the ApoE4 gene, so that it falls under a controlled access program.
“Following this official recommendation from the EMA, which in our opinion is excellent news and very sensible, the Spanish authorities will decide whether this medicine will be financed by the SNS and under what conditions,” notes the SEN.
In any case, he underlines, the study group on behavior and dementia of this company will “soon” formulate some recommendations on the criteria to take into consideration for the correct use of this drug and other similar ones.
Already in 2024, the SEN had expressed concern about the EMA’s decision not to approve the marketing of lecanemab for Alzheimer’s patients, because “its lack of approval has put European centers behind in innovation in this field, not allowing them to “Evaluate the long-term efficacy and safety of this type of new drugs in a routine clinical setting.”
Thus, together with several European scientific societies, they encouraged the EMA to reconsider its decision, arguing that the safety of these drugs could be increased by excluding patients at greater risk of complications and with restrictions.
The benefits outweigh the risks
A year ago, the US Food and Drug Administration (FDA) approved the use of lecanemab, which slows the symptoms of Alzheimer’s disease in patients, an irreversible neurodegenerative disease that destroys memory and the ability to perform tasks.
But the drug, which is administered intravenously, has raised suspicions because of the potential for it to cause inflammation and bleeding in the brain, a condition that occurs in some Alzheimer’s patients, known as ARIA.
However, after reviewing the drug in a smaller population, the EMA concludes that for this profile of Alzheimer’s patients ”Leqembi’s benefits in slowing the progression of symptoms of the disease outweigh its risks” as long as it is used at the same time. time to adopt “risk minimization measures” for the most serious side effects.
“Leqembi will be available through a controlled access program to ensure the drug is only used in patients for whom it is recommended,” he adds. the EMA.
What are the potential side effects of lecanemab for patients with Alzheimer’s disease?
Interview Between Time.news Editor and Dr. Maria Gonzales, Neurology Expert
Time.news Editor (TNE): Thank you for joining us today, Dr. Gonzales. The recent decision by the European Medicines Agency (EMA) to recommend lecanemab for Alzheimer’s patients has sparked significant discussion in the medical community. Can you help us unpack the implications of this decision?
Dr. Maria Gonzales (DMG): Absolutely, thank you for having me. This recommendation is a watershed moment for Alzheimer’s treatment in Europe. For the first time in over 20 years, we have a new therapeutic option that could provide some patients with a measure of relief from the cognitive decline associated with this devastating disease.
TNE: The EMA had previously advised against lecanemab due to concerns about side effects. What has changed to prompt this new recommendation?
DMG: Great question. Initially, the EMA found that the potential side effects, including amyloid-related imaging abnormalities (ARIA), did not justify the benefits. However, recent data showed that the drug is effective specifically for patients who have only one or no copies of the ApoE4 gene — the potential for these patients to experience ARIA is significantly lower. This refined criteria likely influenced the EMA to reconsider.
TNE: This decision is being hailed as “excellent news” by organizations like the Spanish Alzheimer Confederation. What do you think are the broader implications for Alzheimer’s patients in the EU?
DMG: It certainly is a significant development, not just for the patients who qualify but also as a message of hope. It places the EU on par with countries like the United States and the UK. While some patients may only see a 27% reduction in the rate of cognitive decline, it’s a substantial improvement compared to no treatment. It’s critical for families to have options.
TNE: Moving forward, what are the next steps for the drug now that the EMA has recommended it?
DMG: The next phase involves the Spanish Agency for Medicines and Health Products (AEMPS) deciding on its approval and whether it will be included in Spain’s National Health Service. Moreover, the Spanish Society of Neurology indicated plans to establish guidelines for appropriate usage, especially given the controlled access program for high-risk patients.
TNE: How crucial is it that lecanemab is limited to patients with specific genetic profiles, like those with fewer ApoE4 alleles?
DMG: This is very important. By focusing on patients who are less likely to experience severe side effects, we can maximize the effectiveness of the treatment while minimizing potential risks. This stratified approach could lead to better outcomes and also lower the overall burden on healthcare systems.
TNE: The response from the Alzheimer’s community has been one of cautious optimism. How do you see the collaboration between healthcare, regulatory bodies, and patient organizations evolving in light of this news?
DMG: Collaboration will be essential. The input from organizations like Ceafa offers valuable insights into the real-world impact of these decisions. As we embrace innovative treatments, ongoing dialogue between patients, healthcare providers, and regulatory agencies will be necessary to navigate the complexities of treatment access, financing, and patient safety.
TNE: Before we conclude, what message would you like to share with Alzheimer’s patients and their families regarding this new development?
DMG: I want to convey that there is hope. While we may not have a cure yet, every step we take towards new treatments represents progress in our understanding of Alzheimer’s. I encourage families to stay informed and engaged with their healthcare providers, as more options will hopefully come into play in the near future.
TNE: Thank you, Dr. Gonzales, for your insights and for shedding light on this important topic. We look forward to seeing how this progresses in the coming months.
DMG: Thank you for having me. It was a pleasure to share this information.