On 15 April, the European Commission granted EU authorisation for lecanemab to treat mild cognitive impairment (MCI) 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. It 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 (EMA), which concluded that the benefits of this medicine outweighed the risks for this specific population, as long as risk minimisation measures are applied.
More information will soon be available in the Union Register of Medicinal Products.
Read the Commission’s full announcement: https://ec.europa.eu/newsroom/sante/items/879055/en
As for other conditions, authorisation of a first drug with a new mode of action is an important moment for the Alzheimer’s disease community in Europe. Alzheimer Europe therefore welcomes the authorisation of lecanemab by the European Commission, which followed the positive outcome of the European Medicines Agency’s scientific evaluation of the drug.
Today’s authorisation decision also sets strict conditions on the use of lecanemab, as well as clear risk mitigation requirements. We are encouraged by this considered approach to manage risks, and hope that it will allow eligible patients to make individual choices with their treating physicians, based on a personal analysis of risks and benefits.
In the Alzheimer Europe position paper on anti-amyloid therapies, we called for timely, safe and equitable access to these medicines, for those who could benefit from treatment. We now look to companies to adopt reasonable and sustainable pricing policies, and to payers to ensure lecanemab is covered by national reimbursement systems. Healthcare systems must also be adapted, so that people can receive an accurate, timely diagnosis with access to treatment and effective monitoring for potential side effects. The side effects and benefits of lecanemab will need to be communicated to people with early Alzheimer’s disease in realistic terms, in order to allow shared and informed decision-making.
While this is a watershed moment for the community, it also marks the beginning of a much longer journey to build the necessary infrastructure, ensure equity in access, and support patients and their families in making choices that reflect their values and needs.
At the same time, Alzheimer Europe recognises that lecanemab will only benefit a small fraction of people with the disease. The organisation therefore reiterates its call for continued research into other treatment options, including symptomatic therapies, treatments for people in more advanced stages of the disease and with other types of dementia. Alongside our 41 member organisations, from 36 countries across Europe, we remain committed to a holistic approach where treatments are included alongside counselling, support and care of people with dementia and their carers throughout the disease process.