The European Commission has granted marketing authorisation in the European Union for lecanemab (Leqembi) for the treatment of mild cognitive impairment in the early stages of Alzheimer’s disease, under strict conditions. It is for use in people who have only one or no copy of the ApoE4 gene and who have amyloid beta plaques in the brain. 

Lecanemab is the first such medicine to be authorised in the EU. The authorisation is based on the positive scientific assessment of the European Medicines Agency, which concluded that the benefits of this medicine outweighed the risks in a particular population of patients with such disease and as long as risk minimisation measures are applied. Therefore, the EC’s authorisation decision also sets strict conditions on the use of lecanemab, as well as clear risk mitigation requirements.

Lecanemab is indicated for the treatment of adult patients with a clinical diagnosis of mild cognitive impairment and mild dementia due to Alzheimer’s disease (early AD) who are ApoE4 non-carriers or heterozygotes with confirmed amyloid pathology. The lecanemab marketing authorisation applies to all 27 EU member states as well as Iceland, Liechtenstein and Norway.

Lecanemab is the only approved amyloid-beta (Aβ) monoclonal antibody that preferentially binds and clears toxic protofibrils (soluble Aβ aggregates), in addition to targeting and reducing Aβ plaques (insoluble Aβ aggregates). Protofibrils are a key toxic form of Aβ that accumulate in the brain and cause neuronal injury.

The Alzheimer Society of Ireland said the EC’s decision on lecanemab represents a landmark step forward and pivotal moment in the treatment of Alzheimer’s disease. The society said it is essential that Ireland now prepares for the swift integration of lecanemab (and next generation of treatments in the clinical pipeline) into our healthcare system, ensuring that those who can avail of the treatment are able to access it as soon as possible.