The European Medicines Agency recommends treatment of early Alzheimer’s disease with Leqembi
November 15, 2024The European Medicines Agency (EMA) has recommended approving the drug Leqembi (lecanemab) for the treatment of early Alzheimer’s disease in specific patients. This decision comes after a detailed re-examination by EMA’s Committee for Medicinal Products for Human Use (CHMP). Initially, the committee did not support the drug for all early Alzheimer’s patients but after new analysis, it now supports its use in patients with one or no copy of a genetic variation linked to a higher risk of Alzheimer’s disease, called the ApoE4 gene.
What is Leqembi?
Leqembi is a treatment given as an intravenous infusion every two weeks. It works by targeting amyloid-beta, a protein that forms harmful plaques in the brain of Alzheimer’s patients. The treatment helps to remove these plaques and slow the disease’s progression.
Why Only Certain Patients?
The recommendation applies to patients with one or no copy of the genetic variant linked to a high risk of Alzheimer’s disease (ApoE4 gene). Patients with two copies of this gene face a higher risk of amyloid-related imaging abnormalities (ARIA)—brain swelling or small bleeds. In the re-examined data, 8.9% of patients with one or no copy of ApoE4 experienced swelling (ARIA-edema), compared to 12.6% in the broader patient group. Similarly, small bleeds (ARIA-hemorrhage) occurred in 12.9% of this targeted group, compared to 16.9% in the full group. It is important to note that most ARIA events were asymptomatic, meaning patients did not experience noticeable symptoms. However, the use of anticoagulants (medications to prevent blood clots) significantly increases the risk of hemorrhage. Because of this, patients requiring anticoagulants should not be treated with Leqembi until further research clarifies the safety of this combination.
Benefits vs. Risks
Leqembi was shown to slow down cognitive decline. In a re-examination study of 1,521 patients with one or no copy of ApoE4, those treated with Leqembi experienced a reduction in the severity of cognitive problems by 30.3% after 18 months compared with those receiving placebo. This means patients were able to preserve their memory and thinking abilities for longer.
Safety Measures
Due to the risk of ARIA, patients must undergo brain scanning (MRI) before starting Leqembi and at specific points during treatment to monitor for side effects. The company will also provide training for doctors and guidance for patients, ensuring that symptoms like headache, confusion, or dizziness are quickly addressed. Additionally, a safety study will be conducted to track side effects and the long-term impact of Leqembi.
Next Steps
The European Commission will now review this recommendation. If approved, individual EU countries will decide on pricing and reimbursement based on their respective healthcare systems. Leqembi offers hope for people with early Alzheimer's disease, but requires careful monitoring to ensure patient safety and a number of steps are needed before it becomes available to patients in Sweden.
Implications for the REAL AD study
This approval emphasizes the importance of early detection and intervention in Alzheimer's disease, which is in line with the objective of the REAL AD study. Using remote cognitive tests and blood samples, the study aims to assess the feasibility of methods for early detection and screening of Alzheimer's disease. This may in the future facilitate the diagnosis and treatment of Alzheimer's disease, supported by treatments such as Leqembi. By participating in REAL AD, study participants will help prepare healthcare professionals to identify patients with Alzheimer's disease early and reliably, which will be a prerequisite for effective treatment.
Read the official statement here: https://www.ema.europa.eu/en/news/leqembi-recommended-treatment-early-alzheimers-disease