On April 15, 2025, the European Commission made a landmark decision by approving Biogen's Alzheimer's drug Lecanemab, marketed as Leqembi, under strict conditions. This approval marks a significant advancement in the treatment of Alzheimer's disease, as it is the first drug in Europe that targets the underlying disease processes rather than merely alleviating symptoms.
Lecanemab is specifically approved for treating mild cognitive impairment (MCI) in early-stage Alzheimer's patients who have one or no copies of the ApoE4 gene, which is linked to an increased risk of developing Alzheimer's. According to the European Medicines Agency (EMA), the benefits of Lecanemab outweigh the risks for this specific patient group, provided that appropriate risk minimization measures are implemented.
The drug works by reducing harmful amyloid-beta deposits in the brain, which are believed to contribute to the death of nerve cells and the progression of the disease. Unlike previous treatments that only manage symptoms, Leqembi aims to slow the progression of Alzheimer's, potentially delaying cognitive decline by several months.
Dr. Klaus Fließbach, head of the memory clinic at Bonn University Hospital, expressed cautious optimism about the new treatment. He noted, "It is good that patients now have clarity. In Germany, there will soon be another treatment option for Alzheimer's disease. However, this is not the breakthrough that patients and their families hope for. Leqembi cannot cure Alzheimer's disease; it can only delay its progression for a few months, and only for a small group of patients."
Currently, around 1.84 million people in Germany and over 9 million in Europe are living with dementia. The approval of Lecanemab is a glimmer of hope for those affected by Alzheimer's, particularly as it addresses the disease's root causes. However, experts warn that only a small fraction of Alzheimer's patients will qualify for this treatment.
The EMA had initially voted against the approval of Lecanemab in July 2024, arguing that the potential serious side effects did not justify its use. However, this recommendation was revised in November 2024, leading to the eventual approval by the European Commission. The approval process had been complex, with the Commission initially seeking further consultations to clarify outstanding questions regarding the drug's efficacy and safety.
Patients receiving Leqembi will undergo intravenous infusions every two weeks, with each session lasting approximately one hour. Regular monitoring through MRI scans will be necessary to detect potential side effects, including brain swelling and bleeding, which are serious risks associated with the treatment. The treatment is expected to be administered primarily in university hospitals and specialized clinics equipped with the necessary expertise.
Despite the approval, there are still many unanswered questions regarding the drug's effectiveness, particularly in different demographic groups. For instance, studies have indicated a significant disparity in treatment efficacy between men and women, with men experiencing an average of 43 percent slowing in disease progression compared to only 12 percent for women. This raises important questions about the biological differences in how Alzheimer's disease manifests and progresses in different genders.
The financial implications of Lecanemab are also noteworthy. In the United States, where the drug received full approval in July 2023, it costs approximately 23,000 euros per patient per year. In the UK, while the drug was approved in August 2024, the National Institute for Health and Care Excellence (NICE) determined that the costs were not justified by the limited therapeutic success, leading to the refusal of state health service coverage for the treatment. Conversely, Australia has also expressed opposition to the approval of Lecanemab, citing concerns about its side effects.
The Alzheimer Forschung Initiative e.V. (AFI), a non-profit organization dedicated to Alzheimer’s and dementia research, has been at the forefront of advocating for better treatment options. Since its inception in 1995, the AFI has supported over 420 research activities with a total funding of 17.7 million euros and has distributed more than 975,000 educational guides and brochures on dementia.
As the medical community begins to integrate Lecanemab into treatment protocols, it remains imperative to continue researching and understanding the complexities of Alzheimer's disease. The approval of Leqembi is a significant step forward, but it also underscores the ongoing need for comprehensive studies to explore its long-term effects, especially concerning gender differences and the overall efficacy in diverse patient populations.
While the approval of Lecanemab brings hope to many, it is crucial for patients, families, and healthcare providers to remain informed about the treatment's limitations and potential risks. The journey toward finding effective Alzheimer's treatments continues, and with it, the hope for better outcomes for those affected by this devastating disease.
