Reacción a "EMA revises earlier decision and decides to approve lecanemab for Alzheimer's disease"

The news from the European Medicines Agency (EMA) that lecanemab is recommended for treating some people with early Alzheimer’s disease will bring hope to people across Europe affected by Alzheimer’s. However, it is important to note that this treatment is not available to everyone and it is not a cure, people taking lecanemab still have progression of symptoms, albeit more slowly than people without treatment. Further, the treatment comes with risk of brain swelling or bleeding meaning that in addition to frequent drug infusions, people taking lecanemab need brain scans to monitor for side effects.

Lecanemab is an antibody that removes sticky amyloid pathology from the brain. In July 2024, the EMA decided that the benefits did not outweigh the risks of treatment; however a new re-examination of the data by their Committee for Medicinal Products for Human Use reversed this opinion and recommends granting marketing authorization for some people. The recommendation is only for people with who do not carry two copies of the risk gene called apolipoprotein E epsilon 4 (APOE4).  People with 2 copies of the APOE4 gene are at higher risk of potentially dangerous side effects. Around 1 in 50 people have 2 copies of the APOE4 gene in the general population.  The new conclusion from the EMA is that the benefits of lecanemab treatment outweigh the risks for people with zero or one copies of the APOE4 gene.